Daily Intelligence Briefing

Automated aggregation of the latest research, regulatory updates, and industry news.

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6 sources • 100 articles

Getting into the field

Current chiropractor (save your groans I hate the profession as well) who is looking to switch professions ASAP. I’ve owned my own practice for 5 years and the struggle of being ethical and evidence based (anti-subluxation, adjustments don’t cure any

Reddit MedDevToday

UK offshore wind prices come in 40% cheaper than gas in record auction

Article URL: https://electrek.co/2026/01/14/uk-offshore-wind-record-auction/ Comments URL: https://news.ycombinator.com/item?id=46637399 Points: 25 # Comments: 7

Hacker NewsToday

JuiceFS is a distributed POSIX file system built on top of Redis and S3

Article URL: https://github.com/juicedata/juicefs Comments URL: https://news.ycombinator.com/item?id=46637165 Points: 14 # Comments: 8

Hacker NewsToday
AI

'Elite': The Palantir App ICE Uses to Find Neighborhoods to Raid

Article URL: https://werd.io/elite-the-palantir-app-ice-uses-to-find-neighborhoods-to-raid/ Comments URL: https://news.ycombinator.com/item?id=46637127 Points: 126 # Comments: 51

Hacker NewsToday

Zuck#: A programming language for connecting the world. And harvesting it

Article URL: https://jayzalowitz.github.io/zucksharp/ Comments URL: https://news.ycombinator.com/item?id=46636738 Points: 40 # Comments: 18

Hacker NewsToday

Ask HN: Anyone have a good solution for modern Mac to legacy SCSI converters?

Meaning attaching old SCSI drives to modern Macs, not putting SSDs into old Macs. Comments URL: https://news.ycombinator.com/item?id=46636571 Points: 13 # Comments: 23

Hacker NewsToday

Trump issues 25% tariffs on narrow range of semiconductors

The levies, effective Jan. 15, do not cover products used for data centers and consumer applications, per a proclamation signed Wednesday.

MedTech DiveToday

CVEs Affecting the Svelte Ecosystem

Article URL: https://svelte.dev/blog/cves-affecting-the-svelte-ecosystem Comments URL: https://news.ycombinator.com/item?id=46636387 Points: 75 # Comments: 11

Hacker NewsToday

Italy's privacy watchdog, scourge of US big tech, hit by corruption probe

Article URL: https://www.reuters.com/sustainability/boards-policy-regulation/italys-privacy-watchdog-scourge-us-big-tech-hit-by-corruption-probe-2026-01-15/ Comments URL: https://news.ycombinator.com/item?id=46636193 Points: 38 # Comments: 12

Hacker NewsToday
AI

Supply Chain Vuln Compromised Core AWS GitHub Repos & Threatened the AWS Console

Article URL: https://www.wiz.io/blog/wiz-research-codebreach-vulnerability-aws-codebuild Comments URL: https://news.ycombinator.com/item?id=46636093 Points: 28 # Comments: 1

Hacker NewsToday

GitHub Incident

Article URL: https://www.githubstatus.com/incidents/q987xpbqjbpl Comments URL: https://news.ycombinator.com/item?id=46635550 Points: 96 # Comments: 72

Hacker NewsToday

Ask HN: How can we solve the loneliness epidemic?

Countless voiceless people sit alone every day and have no one to talk to, people of all ages, who don't feel that they can join any local groups. So they sit on social media all day when they're not at work or school. How can we solve this? Comments

Hacker NewsToday

Design and Implementation of Sprites

Article URL: https://fly.io/blog/design-and-implementation/ Comments URL: https://news.ycombinator.com/item?id=46634450 Points: 71 # Comments: 50

Hacker NewsToday
Medical Device

UK nurse interested in medical device roles with US travel

I’m a UK-based registered nurse exploring medical device or clinical specialist roles that include frequent US travel. For those in the field — what titles or companies tend to offer this kind of international exposure? submitted by /u/No_Ent

Reddit MedDevToday

Boston Scientific to acquire Penumbra for $14.5B

With the planned purchase, Boston Scientific will gain several thrombectomy devices to remove clots from blood vessels.

MedTech DiveToday

Found: Medieval Cargo Ship – Largest Vessel of Its Kind Ever

Article URL: https://www.smithsonianmag.com/smart-news/archaeologists-say-theyve-unearthed-a-massive-medieval-cargo-ship-thats-the-largest-vessel-of-its-kind-ever-found-180987984/ Comments URL: https://news.ycombinator.com/item?id=46633574 Points: 69

Hacker NewsToday

Apple is fighting for TSMC capacity as Nvidia takes center stage

Article URL: https://www.culpium.com/p/exclusiveapple-is-fighting-for-tsmc Comments URL: https://news.ycombinator.com/item?id=46633488 Points: 364 # Comments: 253

Hacker NewsToday
AI

Medtronic inks deal to build brain computer interface into surgical system

Medtronic will integrate Precision Neuroscience’s Layer 7 cortical interface with its StealthStation surgical navigation system.

MedTech DiveToday
AI

OBS Studio 32.1.0 Beta 1 available

Article URL: https://github.com/obsproject/obs-studio/releases/tag/32.1.0-beta1 Comments URL: https://news.ycombinator.com/item?id=46633429 Points: 119 # Comments: 32

Hacker NewsToday

Show HN: TinyCity – A tiny city SIM for MicroPython (Thumby micro console)

Article URL: https://github.com/chrisdiana/TinyCity Comments URL: https://news.ycombinator.com/item?id=46632768 Points: 96 # Comments: 16

Hacker NewsToday
AI

Digital health funding increases in 2025, spurred by AI: report

Startups raised $14.2 billion last year, the highest funding total since 2022. Health AI companies collected 54% of total funding, according to Rock Health.

MedTech DiveToday

Programming, Evolved: Lessons and Observations

Article URL: https://github.com/kulesh/dotfiles/blob/main/dev/dev/docs/programming-evolved.md Comments URL: https://news.ycombinator.com/item?id=46632039 Points: 40 # Comments: 22

Hacker NewsToday

25 Years of Wikipedia

Article URL: https://wikipedia25.org Comments URL: https://news.ycombinator.com/item?id=46632023 Points: 312 # Comments: 266

Hacker NewsToday

Jiga (YC W21) Is Hiring Full Stack Engineers

Article URL: https://jiga.io/about-us Comments URL: https://news.ycombinator.com/item?id=46631276 Points: 0 # Comments: 0

Hacker NewsToday
Software

The 3D Software Rendering Technology of 1998's Thief: The Dark Project (2019)

Article URL: https://nothings.org/gamedev/thief_rendering.html Comments URL: https://news.ycombinator.com/item?id=46630798 Points: 107 # Comments: 48

Hacker NewsToday

Nao Labs (Open-Source Analytics Agent, YC X25) Is Hiring

Article URL: https://www.ycombinator.com/companies/nao-labs/jobs/KjOBhf5-founding-software-engineer Comments URL: https://news.ycombinator.com/item?id=46629957 Points: 0 # Comments: 0

Hacker NewsToday
Medical Device

medical device career advice

recently broke into medical device sales as a fresh graduate (23) , ( ton of networking and putting myself out there is how I think I got it!) so excited , but nervous about starting and learning the job and adjusting to corporate. Any advice on how

Reddit MedDevToday
AI

Bridging the Trust Gap: Clinician-Validated Hybrid Explainable AI for Maternal Health Risk Assessment in Bangladesh

arXiv:2601.07866v1 Announce Type: new Abstract: While machine learning shows promise for maternal health risk prediction, clinical adoption in resource-constrained settings faces a critical barrier: lack of explainability and trust. This study prese

arXiv AIcs.AIToday

Executable Ontologies in Game Development: From Algorithmic Control to Semantic World Modeling

arXiv:2601.07964v1 Announce Type: new Abstract: This paper examines the application of Executable Ontologies (EO), implemented through the boldsea framework, to game development. We argue that EO represents a paradigm shift: a transition from algori

arXiv AIcs.AIToday

When Models Know When They Do Not Know: Calibration, Cascading, and Cleaning

arXiv:2601.07965v1 Announce Type: new Abstract: When a model knows when it does not know, many possibilities emerge. The first question is how to enable a model to recognize that it does not know. A promising approach is to use confidence, computed

arXiv AIcs.AIToday
Safety

Reasoning over Precedents Alongside Statutes: Case-Augmented Deliberative Alignment for LLM Safety

arXiv:2601.08000v1 Announce Type: new Abstract: Ensuring that Large Language Models (LLMs) adhere to safety principles without refusing benign requests remains a significant challenge. While OpenAI introduces deliberative alignment (DA) to enhance t

arXiv AIcs.AIToday
AI

Internal Deployment Gaps in AI Regulation

arXiv:2601.08005v1 Announce Type: new Abstract: Frontier AI regulations primarily focus on systems deployed to external users, where deployment is more visible and subject to outside scrutiny. However, high-stakes applications can occur internally w

arXiv AIcs.AIToday

Integrating Attendance Tracking and Emotion Detection for Enhanced Student Engagement in Smart Classrooms

arXiv:2601.08049v1 Announce Type: new Abstract: The increasing adoption of smart classroom technologies in higher education has mainly focused on automating attendance, with limited attention given to students' emotional and cognitive engagement dur

arXiv AIcs.AIToday
AI

Forecast Aware Deep Reinforcement Learning for Efficient Electricity Load Scheduling in Dairy Farms

arXiv:2601.08052v1 Announce Type: new Abstract: Dairy farming is an energy intensive sector that relies heavily on grid electricity. With increasing renewable energy integration, sustainable energy management has become essential for reducing grid d

arXiv AIcs.AIToday

A New Strategy for Verifying Reach-Avoid Specifications in Neural Feedback Systems

arXiv:2601.08065v1 Announce Type: new Abstract: Forward reachability analysis is the predominant approach for verifying reach-avoid properties in neural feedback systems (dynamical systems controlled by neural networks). This dominance stems from th

arXiv AIcs.AIToday
AI

Semantic Gravity Wells: Why Negative Constraints Backfire

arXiv:2601.08070v1 Announce Type: new Abstract: Negative constraints (instructions of the form "do not use word X") represent a fundamental test of instruction-following capability in large language models. Despite their apparent simplicity, these c

arXiv AIcs.AIToday
AI

MemoBrain: Executive Memory as an Agentic Brain for Reasoning

arXiv:2601.08079v1 Announce Type: new Abstract: Complex reasoning in tool-augmented agent frameworks is inherently long-horizon, causing reasoning traces and transient tool artifacts to accumulate and strain the bounded working context of large lang

arXiv AIcs.AIToday

MirrorBench: An Extensible Framework to Evaluate User-Proxy Agents for Human-Likeness

arXiv:2601.08118v1 Announce Type: new Abstract: Large language models (LLMs) are increasingly used as human simulators, both for evaluating conversational systems and for generating fine-tuning data. However, naive "act-as-a-user" prompting often yi

arXiv AIcs.AIToday

How vehicles change lanes after encountering crashes: Empirical analysis and modeling

arXiv:2601.08125v1 Announce Type: new Abstract: When a traffic crash occurs, following vehicles need to change lanes to bypass the obstruction. We define these maneuvers as post crash lane changes. In such scenarios, vehicles in the target lane may

arXiv AIcs.AIToday
AI

Embedded AI Companion System on Edge Devices

arXiv:2601.08128v1 Announce Type: new Abstract: Computational resource constraints on edge devices make it difficult to develop a fully embedded AI companion system with a satisfactory user experience. AI companion and memory systems detailed in exi

arXiv AIcs.AIToday

Project Synapse: A Hierarchical Multi-Agent Framework with Hybrid Memory for Autonomous Resolution of Last-Mile Delivery Disruptions

arXiv:2601.08156v1 Announce Type: new Abstract: This paper introduces Project Synapse, a novel agentic framework designed for the autonomous resolution of last-mile delivery disruptions. Synapse employs a hierarchical multi-agent architecture in whi

arXiv AIcs.AIToday

ZeroDVFS: Zero-Shot LLM-Guided Core and Frequency Allocation for Embedded Platforms

arXiv:2601.08166v1 Announce Type: new Abstract: Dynamic voltage and frequency scaling (DVFS) and task-to-core allocation are critical for thermal management and balancing energy and performance in embedded systems. Existing approaches either rely on

arXiv AIcs.AIToday

The Agent's First Day: Benchmarking Learning, Exploration, and Scheduling in the Workplace Scenarios

arXiv:2601.08173v1 Announce Type: new Abstract: The rapid evolution of Multi-modal Large Language Models (MLLMs) has advanced workflow automation; however, existing research mainly targets performance upper bounds in static environments, overlooking

arXiv AIcs.AIToday

Improving LLM Reasoning with Homophily-aware Structural and Semantic Text-Attributed Graph Compression

arXiv:2601.08187v1 Announce Type: new Abstract: Large language models (LLMs) have demonstrated promising capabilities in Text-Attributed Graph (TAG) understanding. Recent studies typically focus on verbalizing the graph structures via handcrafted pr

arXiv AIcs.AIToday

Adapting Rules of Official International Mahjong for Online Players

arXiv:2601.08211v1 Announce Type: new Abstract: As one of the worldwide spread traditional game, Official International Mahjong can be played and promoted online through remote devices instead of requiring face-to-face interaction. However, online p

arXiv AIcs.AIToday

An Axiomatic Approach to General Intelligence: SANC(E3) -- Self-organizing Active Network of Concepts with Energy E3

arXiv:2601.08224v1 Announce Type: new Abstract: General intelligence must reorganize experience into internal structures that enable prediction and action under finite resources. Existing systems implicitly presuppose fixed primitive units -- tokens

arXiv AIcs.AIToday
AI

MPCI-Bench: A Benchmark for Multimodal Pairwise Contextual Integrity Evaluation of Language Model Agents

arXiv:2601.08235v2 Announce Type: new Abstract: As language-model agents evolve from passive chatbots into proactive assistants that handle personal data, evaluating their adherence to social norms becomes increasingly critical, often through the le

arXiv AIcs.AIToday

The End of Reward Engineering: How LLMs Are Redefining Multi-Agent Coordination

arXiv:2601.08237v1 Announce Type: new Abstract: Reward engineering, the manual specification of reward functions to induce desired agent behavior, remains a fundamental challenge in multi-agent reinforcement learning. This difficulty is amplified by

arXiv AIcs.AIToday

Large Artificial Intelligence Model Guided Deep Reinforcement Learning for Resource Allocation in Non Terrestrial Networks

arXiv:2601.08254v1 Announce Type: new Abstract: Large AI Model (LAM) have been proposed to applications of Non-Terrestrial Networks (NTN), that offer better performance with its great generalization and reduced task specific trainings. In this paper

arXiv AIcs.AIToday

T3: Benchmarking Sycophancy and Skepticism in Causal Judgment

arXiv:2601.08258v1 Announce Type: new Abstract: We introduce T3 (Testing Trustworthy Thinking), a diagnostic benchmark designed to rigorously evaluate LLM causal judgment across Pearl's Ladder of Causality. Comprising 454 expert-curated vignettes, T

arXiv AIcs.AIToday

VGG Induced Deep Hand Sign Language Detection

arXiv:2601.08262v1 Announce Type: new Abstract: Hand gesture recognition is an important aspect of human-computer interaction. It forms the basis of sign language for the visually impaired people. This work proposes a novel hand gesture recognizing

arXiv AIcs.AIToday

Sparsity Is Necessary: Polynomial-Time Stability for Agentic LLMs in Large Action Spaces

arXiv:2601.08271v1 Announce Type: new Abstract: Tool-augmented LLM systems expose a control regime that learning theory has largely ignored: sequential decision-making with a massive discrete action universe (tools, APIs, documents) in which only a

arXiv AIcs.AIToday

Internship Advice

I have a phone call with a stryker regional sales manager in MD for upper extremity sales internship next Tuesday. I got my information passed internally and this is my first real interview/chat. What questions should I expect and any advice on prepa

Reddit MedDevToday

Should I leave a good job I enjoy for EP mapping and more potential upside?

Hi friends, I am at a cross roads and want to hear from others in the space their thoughts, or their past experiences. I currently have a TM job with a company I love. I’ve been here a while, and have been successful and widely respected. However

Reddit MedDevToday

Ortho Companies

I get the sense that the big companies (Stryker, Arthrex, Smith and Nephew) are good to get your foot in the door and experience for some money, but what companies are people going after to make these huge salaries that are advertised (200k+)? Are pe

Reddit MedDevToday

“In Process, Preliminary Conversations Underway”

Has anyone’s application said this before? If so, how long does it take to hear back? One of my applications for S+N shows this, so just curious. Thanks! submitted by /u/Willing_Guidance_271 [link] [comments]

Reddit MedDevToday

Cost-effectiveness Analyses for the Prevention of Acute Kidney Injury in Patients Undergoing Cardiac Surgery in the UK

Multi-centre retrospective analysis of prospectively collected data with propensity matched scoring groups (AKI v/s non-AKI). Data collection from databases (or their equivalent): PATS Dendrite, Electronic Medical Records, TD-web (results Portal), Me

ClinicalTrials.govClinical TrialToday

Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea

The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous positive airway pressure (C

ClinicalTrials.govClinical TrialToday

Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Patients - The OPTICal Study

This multicentric randomized controlled trial aims to evaluate whether indirect calorimetry (IC)-guided nutritional support improves patient-centered outcomes in critically ill adult patients compared to standard formula-based nutritional strategies.

ClinicalTrials.govClinical TrialToday

Optimization of NIBS for Treatment of Addiction

The purpose of this study is to assess the effects of transcranial Direct Current Stimulation (tDCS) applied in conjunction with Transcranial Ultrasound (TUS) for the treatment of addiction in opiate use disorder with chronic pain. The investigators

ClinicalTrials.govClinical TrialToday

Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)

This is a prospective, descriptive study. Safety endpoints will not be assessed. All eligible patients that have a history of paroxysmal atrial fibrillation and an indication to undergo Micra AV2 device placement as per standard of care (SOC) across

ClinicalTrials.govClinical TrialToday
Safety

Post-Market Study on the Safety and Effectiveness of the OpHLINE OVD in Cataract Surgery

This post-market clinical study was designed to assess the safety and effectiveness of the OpHLINE Ophthalmic Viscosurgical Device (OVD) as an adjunct in cataract surgery. OpHLINE is a sterile, viscoelastic solution based on high-molecular-weight sod

ClinicalTrials.govClinical TrialToday

Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation

Spinal cord stimulation (SCS) relies on stimulation of pain-relieving pathways in the spinal cord to treat chronic neuropathic pain. Traditional paresthesia-based SCS (PB-SCS) relies on providing analgesia through stimulation of spinal cord dorsal co

ClinicalTrials.govClinical TrialToday

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

Background: Breast cancer is the most common cancer in US women. There are different types of breast cancers; some are aggressive and difficult to treat. Researchers want to know if an algorithm (ENLIGHT) can help choose approved drugs that will tre

ClinicalTrials.govClinical TrialToday
ISO

Early Support for Post-Traumatic Stress Disorder After Difficult Childbirth: Writing and Breathing Interventions

The purpose of this study is to examine two early interventions, Written Exposure Therapy and Capnometry Guided Breathing, to reduce post-traumatic stress disorder (PTSD) symptoms in women after childbirth as compared to usual care.

ClinicalTrials.govClinical TrialToday

A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD

The purpose of this multicenter, prospective cohort study is to investigate the correlation of real-world sensor-derived biometric data obtained via a wearable device with clinical parameters and patient-reported outcomes (PROs) for monitoring diseas

ClinicalTrials.govClinical TrialToday
AI

CAS Medtronic Training

Has anyone done the CAS training for Medtronic? If so how hard was it? How hard are the exams? I saw you need a 90% to pass…. Are the questions difficult? Are the weekly module quizzes a good reflection of the exams? What happens if you fail an exam?

Reddit MedDevYesterday

Design Verification Build

Hi folks, What are the minimum requirements for conducting a Design Verification build at a contract site? DV Build Protocol Component Specs BOM Anything else required specifically for building out the units for DV? Thanks! submitted

Reddit MedDevYesterday

Is this typical for LINET?

I applied for the clinical specialist position at LINET Americas. believe I did well for the HR interview but didn’t take into account the holidays (my initial interview was 12/11, hr interview timeline: 12/09-12/19, and HR said start dates should be

Reddit MedDevYesterday

Anyone here works for JnJ or Stryker and can tell me if this is normal or not?

I had a virtual Interview (one of those due within these few days) for both companies on Dec 11&12. I just haven't heard back but on the candidate home page it either says in process or application received. I went ahead and sent a follow up email a

Reddit MedDevYesterday

Clinical Specialist compensation expectations

I recently started the application process for a Clinical Specialist, Pain Management role and am transitioning into medical devices from organ recovery. I have extensive clinical and OR experience, frequent physician interaction, and a bachelor’s de

Reddit MedDevYesterday

Just starting my job, have some questions?

I graduated in December and accepted a position that I started full time last week. I sell mostly into the OR and it’s a mix of capital and disposable. My question is, when you’re visiting hospitals or ASC’s, what all do you typically bring with you?

Reddit MedDevYesterday

Actual amount of travel?

Noticing a lot of job postings for clinical specialists in my area. Most of them say 75% or 80% travel. I am wondering what this really means. Does it actually mean being away 5 days/week for 3 weeks each month (on average)? What is your experience

Reddit MedDevYesterday

5 topics to watch as MDUFA negotiations restart

The next Medical Device User Fee Amendments, which will set how much the FDA can raise from the industry in fees over a five-year period, are expected to go to Congress this year.

MedTech DiveYesterday
FDAAI

Boston Scientific gains FDA’s OK for new PFA catheter

The Farapoint device adds another tool to the company’s pulsed field ablation portfolio that could help increase or sustain its electrophysiology market share, one analyst said.

MedTech DiveYesterday
Software

Software engineering jobs?

Hi, I’ve worked for 3 years as a software engineer in a Europe based medical device manufacturing company, mainly in vitro diagnostics. I’ve been looking for companies that do kind of the same thing(and are hiring) but didn‘t have too much success.

Reddit MedDevYesterday

Smith & Nephew to acquire Integrity Orthopaedics for up to $450M

The company has committed the cash, half of which it is paying upfront, to buy Integrity Orthopaedics for its rotator cuff repair system.

MedTech DiveYesterday
Medical Device

R&D Advice- Medical Devices

submitted by /u/Radiant_Wolverine541 [link] [comments]

Reddit MedDevYesterday

Getting in from clinical

Hi, long time lurker here. I’ve been working my way to getting into the R&D side of medical devices since the start of my career but it has been proving rather difficult and i’m wondering if i’m just being shortsighted or should i make some big car

Reddit MedDevTue, Jan 13

Intuitive Surgical Verbal to Written Offer

Hi guys, for people who are/used to working at Intuitive, how long did it take from verbal offer to receive a written one? I got a verbal offer last Friday, wondering if I should follow up. submitted by /u/Gutyenkhuk [link] [comments]

Reddit MedDevTue, Jan 13

Job offer very low

Hello all, I’ve wanted to transition into medical device sales or dental sales. The role I have been offered (medical device sales), with OTE is 50% what I’m making currently. I have zero medical device sales experience. Do I have any leverage to neg

Reddit MedDevTue, Jan 13
FDA

Medtronic gets FDA clearance for smart insulin pen app

The app pairs Medtronic’s smart insulin pens with a sensor made by Abbott.

MedTech DiveTue, Jan 13

Inspire appoints Matt Osberg as CFO

While Osberg joins Inspire without prior medtech experience, CEO Tim Herbert says the new CFO can help take the company “to the next level.”

MedTech DiveTue, Jan 13
AI

Medical field service technician roles in Spain or Canada

What companies medical devices minimal invasive instruments/ integrated rooms. Without having to do sales or tied to some sales quota. How big of a demand is there , what challenges will one expect. Has anyone made the transition from USA to Spain or

Reddit MedDevTue, Jan 13
Medical Device

Medical devices - Abbott

submitted by /u/Key_Sorbet_2479 [link] [comments]

Reddit MedDevTue, Jan 13

Anyone else deal with re-scheduling, cancellations, and CRM double entry in med device sales?

Hello! I’m a field rep in medical devices and wanted to see if others here deal with the same headaches I do. A big part of my role is coordinating appointments with clinics and offices, and honestly the most frustrating part isn’t the selling but

Reddit MedDevTue, Jan 13
FDA

FDA Approves First Treatment for Children With Menkes Disease

The U.S. Food and Drug Administration today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients.

FDA NewsRegulatoryMon, Jan 12

Boston Scientific to buy incontinence device maker Valencia

The deal would set up Boston Scientific to compete with Medtronic in the market for neuromodulation devices that work by stimulating the tibial nerve.

MedTech DiveMon, Jan 12
AI

Should i accept a clinical specialist job if my aim is to get into R&D?

Hello everyone, I am finishing my masters in biomedical engineering and I just had a recruiter reach out to me for a clinical specialist role. Specifically i would be doing heart mapping during operations via Carto 3 (a Johnson & Johnson device). As

Reddit MedDevMon, Jan 12
FDAClinical Trial

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient

FDA NewsRegulatoryMon, Jan 12
FDAInnovation

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and gene therapies (CGT).

FDA NewsRegulatorySun, Jan 11
FDASafety

FDA Finds Insufficient Data to Determine Safety of PFAS in Cosmetic Products

The U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic product

FDA NewsRegulatoryMon, Dec 29

New Year - New Rule

Hi all, We have implemented a new community rule: Rule #2: Read the Wiki and search the sub before posting. We have built out the Sales section of the wiki sufficiently to address the frequent “breaking into medical device sales” questions. This is

Reddit MedDevTue, Dec 23
FDA

FDA Grants Two National Priority Vouchers

The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for Am

FDA NewsRegulatoryFri, Dec 19
FDAInnovation

FDA Explores New Contracting Approach to Advance Public Health Innovation

The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach to strengthen collaboration between the agency and America’s most innovative companies.

FDA NewsRegulatoryFri, Dec 19
FDARecall

FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula

The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation

FDA NewsRegulatoryMon, Dec 15
FDA

FDA Eliminates Major Barrier to Using Real-World Evidence in Drug and Device Application Reviews

The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications reviews.

FDA NewsRegulatoryMon, Dec 15
FDA

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results

The U.S. Food and Drug Administration today awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma.

FDA NewsRegulatoryMon, Dec 15
FDA

FDA Approves Two Oral Therapies to Treat Gonorrhea

The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea.

FDA NewsRegulatoryFri, Dec 12

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