European Commission targets spring of 2024 for fully functional Eudamed database

The Commission is planning a two-phase transition to mandatory use of the database after it goes live.

By Nick Paul Taylor • July 11, 2022

Labcorp starts offering monkeypox testing using the CDC's PCR test

Labcorp claims it will become the first national laboratory to offer the test by beating its chief rival to market.

By Nick Paul Taylor • July 8, 2022

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

High-risk IVD tests rules finalized by European Commission despite industry calls for change

MedTech Europe pushed back against some of the requirements, but the Commission has retained disputed parts of the document.

By Nick Paul Taylor • July 8, 2022

SD Biosensor agrees to buy Meridian Bioscience for $1.53B in bid to enter U.S. IVD market

The Cincinnati-based diagnostics company says being acquired will help it enter new markets as part of SD Biosensor, as the COVID-detection business wanes.

By Elise Reuter • July 7, 2022

Semiconductor shortage leaves medtech industry 'more pessimistic' as customers leave, says Deloitte

Hospitals and health systems are looking into alternative products as a result of the disruption, according to a report from Deloitte and AdvaMed.

By Nick Paul Taylor • July 7, 2022

American Contract Systems' COVID-19 test recall gets Class I label from FDA

Off-site assembly by workers who may not have been properly trained prompted the company to recall COVID-19 tests amid concerns they may yield false results. 

By Nick Paul Taylor • Updated July 6, 2022

COVID-19 antigen test sensitivity could be as low as 60% with omicron: FDA

The tests have taken a “really big hit in sensitivity” with the omicron variant, raising doubts about the ability of a single test to provide a definitive diagnosis, according to the agency.

By Elise Reuter • July 5, 2022

AliveCor ECG patent ruling sets stage for block on Apple Watch imports

Apple Watch imports to the U.S. could be barred if ruling by International Trade Court judge is finalized; Judge says Apple Watch infringes two cardiogram patents.

By Nick Paul Taylor • July 5, 2022

Friday Q&A: Canary Medical CEO Bill Hunter discusses knee-implant sensors, device reimbursement

Canary’s founder discusses how the firm plans to create predictive tools from data collected by the devices, and long-term plans to embed its sensors in other implants.

By Elise Reuter • July 1, 2022

LiveMetric's blood-pressure 'smartwatch' device gets FDA clearance

The wristwatch-like device will be made available through health systems, insurers and self-insured employers to ease continuous monitoring of blood pressure and avoid white-coat syndrome.

By Nick Paul Taylor • July 1, 2022

Intuitive secures FDA clearance for lung biopsy robot featuring Siemens' imaging tech

The FDA clearance is an “incremental positive” for Intuitive, wrote analysts at RBC Capital Markets, adding that they see Ion as “an important leg of growth for the company.”

By Nick Paul Taylor • July 1, 2022

Commercial labs to ramp up monkeypox testing in 'coming weeks'

The Food and Drug Administration said in a Wednesday meeting that public health labs currently have a throughput of 10,000 tests per week, and the addition of five reference labs will expand that capacity to 60,000 tests per week.

By Elise Reuter • June 29, 2022

Cue Health cuts 170 jobs amid 'economic challenges,' decline in COVID-19 testing

With a contract to test the National Basketball Association, IPO funding and a $481 million government contract, Cue Health grew its headcount more than 10-fold in the pandemic.

By Nick Paul Taylor • June 28, 2022

UnitedHealth's Optum looks to cut down on unnecessary lab testing

Optum says roughly 13 billion clinical lab tests are performed each year and 30% are unnecessary.

By Samantha Liss • June 27, 2022

A digital point-of-care primer for medtech marketers

Technology advances are creating new opportunities in the care journey as digital point-of-care becomes part of patients’ and providers’ daily lives.

June 27, 2022

Medtech M&A falls 85% but activity could rebound in second half: report

PwC highlights a range of barriers that could stop acquisitions, including supply chain issues, scrutiny from the Federal Trade Commission and geopolitical concerns.

By Nick Paul Taylor • June 24, 2022

Lack of clinical evidence 'major gap' in digital health: study

The researchers framed the low scores as evidence of “a major gap in health care technology,” adding that there is a “significant opportunity” for companies that differentiate themselves with a more rigorous approach.

By Nick Paul Taylor • June 22, 2022

Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe

Senseonics is looking to the longer-lasting implant to re-energize its fight in a market dominated by Abbott Laboratories and Dexcom.

By Nick Paul Taylor • June 17, 2022

User fee package goes to Senate with lab-developed test, OTC hearing aid provisions

The Senate HELP committee passed its version of the FDA user fee bill by a 13-9 vote. It includes an overhaul of diagnostic testing regulations and a requirement to create a category of over-the-counter hearing aids.

By Elise Reuter • June 15, 2022

DHS warns cybersecurity vulnerabilities in Illumina software could affect test results

Three of the flaws outlined by the Department of Homeland Security received the highest risk score. Vulnerabilities could allow attackers to remotely alter the results generated by Illumina products.

By Nick Paul Taylor • June 6, 2022

GE Healthcare says contrast media production back to full capacity

The shortage of the injectable used for medical imaging started in April, when the company’s plant in Shanghai shut down due to rising COVID-19 cases.

By Nick Paul Taylor • Updated June 17, 2022

FDA to start accepting all pre-submissions for in vitro diagnostics

The agency had previously declined pre-submission requests unless they were related to COVID-19. Test developers should expect an extended timeline for reviews amid a backlog of pandemic-related submissions. 

By Elise Reuter • June 1, 2022

Baxter raises forecasts for Hillrom synergies, allaying concerns over $10.5B takeover

Company executives said the additional cost savings emerged as they took a closer look at Hillrom’s real estate footprint.

By Nick Paul Taylor • May 26, 2022

Proposed LDT regulations has diagnostics industry, consumer groups at odds

Consumer advocates say the proposed legislation has too many exemptions and doesn’t provide adequate protections for patients, while industry groups seek to limit premarket review requirements of legacy tests.

By Elise Reuter • May 25, 2022

Medtech companies keep supply, staffing challenges in check even as recession risks loom: analysts

Companies are coping with factors such as supply disruptions, staffing shortages, inflation and foreign-exchange hurdles, according to William Blair analysts.

By Nick Paul Taylor • May 24, 2022