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

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

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

Senate seeks to reform diagnostic oversight via user-fee bill, sparking mixed response

The revised bill from the Senate features a modified version of the Verifying Accurate Leading-edge IVCT Development Act that split the diagnostic industry when lawmakers previously tried to pass it.

By Nick Paul Taylor • May 23, 2022

FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations

The House Energy and Commerce Committee unanimously passed a bill to reauthorize the FDA’s user-fee amendments for the next five years. A Senate committee draft of the bill would add substantive changes.

By Elise Reuter • May 19, 2022

LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19

The kit allows individuals to self-collect nasal swab samples at home to send to LabCorp, which will test for the presence of influenza A and B, respiratory syncytial virus and SARS-CoV-2.

By Nick Paul Taylor • May 18, 2022

FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests

Woodside Acquisitions recalled two different rapid antigen test kits last month and sent emails to distributors requesting them to immediately return all unused products for a refund.

By Nick Paul Taylor • May 16, 2022

FDA needs testing enforcement discretion policy to improve crisis response, GAO finds

The U.S. Government Accountability Office has recommended that the FDA develop a policy about when to start and stop enforcement discretion for unauthorized tests to avoid some of the problems it faced during the pandemic.

By Nick Paul Taylor • May 13, 2022

Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market

The company plans to work toward approvals of transplant assays for other pathogens including the BK virus and Epstein-Barr virus to provide quantitative assessments of potential threats to patients.

By Nick Paul Taylor • May 12, 2022