Medtech Insight RSS Feed - Infectious Diseases

LSI Panel Says Women’s Health Breaks Out Of ‘Bikini Box’ As New Business Models Catch Investors’ Eye

Marion Webb — Fri, 03 Apr 2026 22:36:03 +0000

For years, women’s health has been narrowly defined as fertility, pregnancy and a handful of screening tools. At the LSI USA conference in Dana Point, CA, a panel of women’s health company leaders and

FDA Releases Trove Of Data On Use of Real-World Evidence In Device Clearances

Elizabeth Orr — Fri, 03 Apr 2026 21:57:35 +0000

Manufacturers seeking US Food and Drug Administration guidance on how to use real-world evidence (RWE) in device submissions now have a broad range of new examples to draw from. An April 2 report titl

No Evidence Of Benefit: Two Trials Prompt Calls to End Routine Use Of J&J’s Impella Heart Pump

Shubham Singh — Fri, 03 Apr 2026 17:08:17 +0000

The clinical evidence base for Johnson & Johnson’s Impella miniaturized heart pumps has been called into question by two randomized trials presented at the American College of Cardiology’s annual

Washington Sleep Doctor Gets Year In Prison For Distributing Recalled Philips CPAP, BiPAP Devices

Elizabeth Orr — Fri, 03 Apr 2026 16:04:12 +0000

A Washington state sleep doctor has been sentenced to a year and a day in prison for distributing recalled Philips Respironics continuous positive airway pressure (CPAP) and BiPAP (Bilevel Positive Ai

Execs On The Move: March 23–27, 2026

Medtech Insight Team — Thu, 02 Apr 2026 17:36:14 +0000

Whoop Raises $575M At $10.1Bn Valuation With Abbott on Board As Oura And Google Close In

Shubham Singh — Thu, 02 Apr 2026 16:03:44 +0000

Whoop has raised $575m in a Series G financing round that values the Boston-based wearable device company at $10.1bn, with Abbott joining as a strategic investor alongside Mayo Clinic and lead investo

Force Majeure, 35% Spike In Plastics Costs: Middle East Conflict Hits Medical Supply Chains

Shubham Singh — Thu, 02 Apr 2026 15:50:28 +0000

Five weeks into the war in Iran, the risk of disruption to petrochemical distribution feeding through to medical supply chains is no longer a theoretical risk – it is a declared operational reality fo

China Issues Global-First Approval For SPECT/CT Imaging Agent For Tumor Diagnosis

Dexter Jie Yan — Thu, 02 Apr 2026 09:14:34 +0000

China has greenlighted the world’s first imaging agent that can be used in single photon emission computed tomography/X-ray computed tomography (SPECT/CT) scans for assisted diagnosis of tumors, the N

Industry Underprepared for QMSR Launch, Survey Finds

Elizabeth Orr — Wed, 01 Apr 2026 21:45:25 +0000

More than half of medtech firms were not highly prepared for the US Food and Drug Administration’s major quality management system reworking, a new survey from quality management software vendor Grand

US FDA Should Show Its Work on AdComm Conflict of Interest Decisions, GAO Says

Bridget Silverman — Wed, 01 Apr 2026 18:46:34 +0000

The US Food and Drug Administration advisory committee system continues working without published guidance on assessing members’ conflicts of interest more than 13 years after legislation required it

MedTech Europe Calls For Coordinated Wound Care Policy

George Underwood — Wed, 01 Apr 2026 12:14:51 +0000

Chronic wound care is a growing burden across Europe, but could be mitigated by better care coordination, real-word datasets and AI tools. That is according to a new report from MedTech Europe, which

Menopause, Heart Disease, Alzheimer’s Are All Part Of Women’s Health, Industry Leaders Say

Marion Webb — Tue, 31 Mar 2026 23:19:58 +0000

Women’s health investment is increasingly framed as one of the largest untapped opportunities and is expected to reach more than $600bn by 2030, according to PwC. Yet the lion’s share of funding conti

Boston Scientific Eyes Expanded Watchman Indication After CHAMPION-AF Results; Analysts Flag Caveats

Shubham Singh — Tue, 31 Mar 2026 19:09:43 +0000

The CHAMPION-AF trial has delivered the data Boston Scientific needed to pursue a broader indication for its Watchman FLX left atrial appendage closure device. Presented at the American College of C

Practicalities For AI-Enabled Devices As Digital (R)evolution Picks Up Pace

Ashley Yeo — Tue, 31 Mar 2026 18:20:46 +0000

Digital and AI-enabled medical device innovators are learning new codes of regulatory compliance while at the same time developing software engineering and data science expertise, overseeing steering

Perspective: Navigating Medical Device Development From Bench To Market

Partha Anbil|Saravanan Manikandan — Tue, 31 Mar 2026 14:15:13 +0000

The medical device sector continues its fundamental transformation. While innovative ideas emerge from academic laboratories and start-up ecosystems, the path to commercialization has become simultane

Former CMS Top Official Says Brain-Computer Interface Development Outpaces CMS Coverage

Marion Webb — Mon, 30 Mar 2026 17:49:56 +0000

Implantable brain-computer interfaces (iBCI) hold tremendous potential to help people with severe neurological disabilities communicate with the outside world. But experts warn that without a clear Me

Five-Minute Podcast: ‘UK Must Align More With EU’

Ashley Yeo — Mon, 30 Mar 2026 12:27:53 +0000

Medtech Insight caught up with Gerard Hanratty, head of health and life sciences at UK and Ireland law firm Browne Jacobson, to get his concise take on regulatory alignment in global markets, includi

Adapt To Survive: Private Hospitals In A High-Pressure Landscape

Ashley Yeo — Mon, 30 Mar 2026 10:02:04 +0000

Private hospitals know that value creation opportunities are there for the taking, but they are often unsure of which levers to pull for maximum success within their organization. So said Jean-Philipp

FDA Finalizes Guidance On Including Patient Preference Information In Device Submissions

Brian Bossetta — Fri, 27 Mar 2026 20:44:55 +0000

Device makers looking to boost their chances of getting their products through the regulatory process should consider the patient perspective. The Food and Drug Administration says patients can offer

Cancer Biomarker Test Advertising Largely OK, NAD Says

Elizabeth Orr — Fri, 27 Mar 2026 17:24:19 +0000

Marketing for a test to detect certain biomarkers associated with oral cancer can stand after just a few tweaks, the BBB National Programs’ National Advertising Division (NAD) said in a ruling issued