Friday Q&A: Ian Lipkin, Columbia epidemiologist, talks COVID-19 testing as U.S. sees another wave

Lipkin explained why he’s not a fan of antigen tests, and stressed the need to keep PCR testing a core part of the pandemic response.

By Elise Reuter • July 15, 2022

Abbott, Intuitive, J&J to kick off quarterly earnings season next week as recession threat looms

Earnings results are poised to set expectations for the impact of a potential slowdown and shed light on trends with implications for companies including Boston Scientific, Medtronic and Stryker.

By Nick Paul Taylor • July 15, 2022

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

Labcorp launches blood test for neurodegenerative disease biomarker

The test could detect Alzheimer’s before it manifests in routine imaging or clinical symptoms, helping physicians assess the effectiveness of treatments.

By Nick Paul Taylor • July 14, 2022

EC publishes IVDR guidance in absence of completed Eudamed database

The commission recently announced a timeline for complete implementation of Eudamed, aiming for the second quarter of 2024.

By Ricky Zipp • July 13, 2022

With COVID testing on the wane, small diagnostics companies shift focus

Startups that grew quickly from large contracts are looking nervously to a new future, as demand plummets for mass testing and shifts to homes.

By Elise Reuter • July 13, 2022

Quest launches monkeypox PCR test as U.S. attempts to catch up with rising cases

The company estimates it will be able to process 30,000 tests per week by the end of July. As of July 12, there were 929 confirmed cases in the U.S., the CDC reported.

By Ricky Zipp • July 13, 2022

Medtronic lands option to buy artery disease player CathWorks for up to $585M

CathWorks has the right to compel Medtronic to complete the acquisition if it chooses not to exercise its option.

By Nick Paul Taylor • July 13, 2022

Hologic, Thermo Fisher roll out respiratory panels for Europe ahead of cold and flu season

Australia’s experience suggests Europe and other parts of the northern hemisphere may face high levels of respiratory disease this winter.

By Nick Paul Taylor • July 12, 2022

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

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