Scrip Infectious Diseases

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

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

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

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

Use AI As Your Copilot, Not Autopilot, When Navigating Diagnostics

Brian Bossetta — Tue, 24 Mar 2026 21:11:59 +0000

The medtech industry is benefiting from the rapid adoption of AI into diagnostics. According to the American Medical Association, 66% of physicians reported using AI in 2025, while only 38% reported u

MEPs Vote To Delay And Simplify AI Act Rules For Medical Devices

George Underwood — Fri, 20 Mar 2026 13:10:16 +0000

Members of two European Parliament committees voted on March 18 to simplify certain rules within the EU AI Act on high-risk systems, including medical devices, and delay their entry in force until Aug

EPA Says Biden-era EtO Standards Threaten Medical Device Access And Supply Chain Security

Brian Bossetta — Tue, 17 Mar 2026 21:03:01 +0000

The medtech industry is embracing a proposal from the Environmental Protection Agency that would water down restrictions the Biden administration imposed on the use of ethylene oxide (EtO) for sterili

FDA Weight Loss Device Guidance Calls For Patient Focus

Elizabeth Orr — Fri, 13 Mar 2026 22:52:17 +0000

Patient-reported outcomes should be considered when evaluating the benefits and risks of a device indicated for weight loss, the US Food and Drug Admission says in a new final guidance document . The

FDA Weighs Second Citizen Petition On Bamboo Health’s NarxCare

Mark McCarty — Wed, 11 Mar 2026 21:44:59 +0000

A citizen petition being considered by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) asks the agency to declare that Bamboo Health Inc.’s NarxCare platform

FDA Announces May Rollout For MAUDE Replacement

Elizabeth Orr — Wed, 11 Mar 2026 18:01:21 +0000

The Manufacturer and User Facility Device Experience (MAUDE) has collected adverse event reports from manufacturers, clinicians and others for almost 30 years. And in May, all that will come to an end

ExThera Medical And Exec Face Legal Consequences After Deaths

Elizabeth Orr — Tue, 10 Mar 2026 20:38:21 +0000

The hope that a blood filtration device from California-based ExThera Medical could slow or stop the progression of cancer was enough to draw patients to a clinic in the Caribbean island nation of Ant

Global Medtech Guidance Tracker: February 2026

Sabah Peerzade — Fri, 06 Mar 2026 19:35:14 +0000

Thirty-eight guidance documents on medical devices and diagnostics issued by regulatory authorities from around the world were added to Medtech Insight’s Guidance Tracker in the past month. The upda

Don’t Use Anti-Choke Devices Unless Other Options Fail, FDA Says

Brian Bossetta — Thu, 05 Mar 2026 18:51:03 +0000

The US Food and Drug Administration says anti-choking devices, even if approved by the agency, should only be used after more effective methods have been tried. In a recent safety communication , the

Clinical Trial Violations And CGMP Failures Subject Of Pair Of New Warning Letters

Brian Bossetta — Wed, 25 Feb 2026 20:04:54 +0000

In a Feb. 6 warning letter to ExThera Medical Corporation, the Food and Drug Administration says the California-based device marketed its products without premarket authorization and failed to compl

FDA Webinar Details Updates To Real-World Evidence Policy

Elizabeth Orr — Mon, 23 Feb 2026 23:32:34 +0000

Sponsors preparing medical device submissions for the US Food and Drug Administration will need to comply with new agency guidance on the use of real-world evidence (RWE), agency staff said during a F

Class I Recalls Rose In 2025, Despite Drop In Overall Number

Brian Bossetta — Thu, 19 Feb 2026 21:46:55 +0000

The total number of medical device recalls dropped in 2025, but that doesn’t point to a positive trend. That’s because class I recalls, the US Food and Drug Administration’s most serious type, reached

FDA Holds ‘Refresher’ Town Hall On Low-Risk, General Wellness Medical Devices

Brian Bossetta — Thu, 12 Feb 2026 21:17:02 +0000

The US Food and Drug Administration wants to reduce the regulatory burden on low-risk technologies, according to Henry Roberts, digital health specialist at the agency’s Office of Strategic Partnershi

QSIT, Lose It! FDA Inspections Will Now Take a Comprehensive Risk-Based Approach

Brian Bossetta — Tue, 10 Feb 2026 22:37:22 +0000

Device manufacturers will now have to demonstrate how they are accounting for risk throughout their company when investigators from the Food and Drug Administration show up to inspect their facilities

MDUFA VI Negotiations Turn To RWE Strategy, Presubmission Reforms

Elizabeth Orr — Tue, 10 Feb 2026 22:22:09 +0000

Real-world evidence and potential improvements to the de novo and presubmission programs were key topics at a recent medical device user fee negotiation meeting, according to minutes posted online F