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COVID-19 Watch

Set Alert for Medtech Insight - Coronavirus COVID-19

Biden’s China Tariffs Mark A Major Shift In US Policy, Analysts Say

A new round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

Trade Policy Asia Pacific

FDA Warns: Government-Funded COVID-19 Test Not On Cue

The US FDA is warning against the use of Cue Health’s COVID-19 test, which was developed and manufactured with $481m of government funding. A recent inspection found unauthorized alterations to the product.

Regulation Safety

At-Home Health Testing Demand Is High Post-Pandemic, But So Are Barriers To Development And Use

At the recent Precision Med-Tri Con conference, laboratory experts traded views on the expansion of at-home testing for disease diagnosis and personalized health insights. While strong consumer demand spells opportunity, there are significant concerns about the accuracy and reliability of home-testing platforms, misuse, accessibility, and lack of health literacy.

Innovation In Vitro Diagnostics

Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

Manufacturing OTC Devices

What Devices Are Essential During A National Emergency? FDA Panel Makes A List

Members of the US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee met on 6 February to discuss what medical devices are critical to public health during a national emergency and help the FDA create a list of those devices.

FDA Advisory Committees

Califf Touches On A Range Of Issues And Priorities During Fireside Chat

During a recent webinar hosted by the Alliance for a Stronger FDA, commissioner Robert Califf discussed the agency’s 2024 budget, its ongoing reorganization, AI, LDTs, and the continuing problem of misinformation.

FDA Policy

‘Banner Year’ For FDA’s Device Center Includes Record Number Of Novel Authorizations

A new annual report argues that last year was both transformative and historic for the US FDA’s Center for Devices and Radiological Health. The center authorized the highest number of novel medical devices in history while turning the corner on the pandemic.

FDA Policy

New FDA List Shows 18 COVID-19 Tests With Traditional Authorization

Manufacturers including BioFire, Cepheid and Roche have already secured multiple 510(k) or de novo clearances from the US FDA. However, more than 400 COVID-19 diagnostics remain on the market under EUAs.

Coronavirus COVID-19 Approvals

Former Diagnostics CEO Pleads Guilty In Securities Fraud Case

Keith Berman claimed to investors that his company, Decision Diagnostics, was on the verge of releasing a groundbreaking COVID-19 test. The problem? It wasn’t true. 

Policy Legal Issues

FDA Issues Final Guidance On Device Shortage Reporting, Adds Device List

The US FDA has published final guidance requiring firms to notify the agency about significant manufacturing interruptions of medical devices during a public health emergency, as well as a supplementary draft guidance that includes a list of specific devices that manufacturers must report to the agency when they are in short supply.

FDA Regulation

News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope

This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.

Regulation Coronavirus COVID-19

Flowflex Becomes First At-Home COVID-19 Antigen Test Cleared Through 510(k)

The test is among the first of a wave of products initially authorized for emergency use by the US FDA that are now pursuing traditional approval pathways to stay on the market. 

Approvals FDA

Amazon To Offer Prime Members Low-Cost Access To One Medical Primary Care

Amazon announced it will offer Prime members a One Medical subscription for $9 a month, or $99 a year in a move to “make it easier for people to get the health care they need.”

Launches Telehealth

Prepping For Flu Will Boost Pandemic Readiness, Baldwin Says

Legislation introduced in the US Senate by Wisconsin’s Tammy Baldwin would beef up the nation’s flu preparedness by investing in new technology for vaccine and diagnostic development as well as treatments.

Policy Legislation

News We’re Watching: AGs Push For Pulse Ox Warnings. VP Harris Announces AI Initiatives; FDA Looks At Digital Health And Diabetes

This week, 25 state attorneys general pressed FDA Commissioner Robert Califf to improve pulse oximeter safety warnings; MDIC extended the deadline on an industry cybersecurity benchmark study; and more guilty pleas and settlements were entered in Medicare fraud cases.

News We're Watching Regulation

Report: Problems At CDC Delayed First COVID-19 Test

Lack of laboratory quality management procedures and resource shortages were behind the CDC’s troubles in developing a COVID-19 diagnostic in 2020, an HHS OIG audit found.

Coronavirus COVID-19 Policy
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