Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail

The DNA-sequencing company said the activist investor hasn’t offered any better solutions for satisfying regulators’ concerns about the acquisition.

By Susan Kelly • March 20, 2023

FDA sets end date for raft of COVID-related shortages that began early in pandemic

Shortages of home-use ventilators and clinical sample concentrators are expected to continue.

By Nick Paul Taylor • March 20, 2023

Medtech trade group pushes UK to support ambitious Software as a Medical Device program

Reams of data collected by the National Health Service, paired with advanced work in artificial intelligence at U.K. universities, could make Britain a digital health leader if the government acts. 

By Nick Paul Taylor • March 15, 2023

QuidelOrtho COVID test is first to win FDA nod via premarket review

Special controls instituted by the FDA as part of the De Novo assessment pave the way for other tests to come to market without pandemic-era Emergency Use Authorization.

By Nick Paul Taylor • March 9, 2023

Abbott gets FDA nod on lab blood test for concussion

Results are available in about 18 minutes and can rule out the need for a CT scan if negative, the company said.

By Susan Kelly • March 8, 2023

iRhythm, fighting Boston Scientific for market share, shows cardiac monitor beats rivals

An analysis of Medicare claims data found iRhythm Technologies’ Zio XT outperforms other ambulatory cardiac monitors.

By Nick Paul Taylor • March 8, 2023

Phone app tracks cough frequency in tuberculosis trial, opening up monitoring opportunity

If validated in further studies, the work could further expand the use of smartphones as diagnostic tools, particularly in areas where there are few medical professionals, and could help stop overtreatment of TB.

By Nick Paul Taylor • March 6, 2023

FDA moving ahead with rulemaking on lab developed tests without waiting for Congress: BioWorld

A senior FDA official said the agency cannot “just stand by” given the failure of Congress to pass legislation addressing regulation of the increasingly complex tests.

By Nick Paul Taylor • March 2, 2023

Remote patient monitoring increasingly popular, even as pandemic eases, analysis of insurance claims shows

Cardiologists are the main users of RPM devices, with blood pressure diagnoses accounting for more than half of all claims made in 2021. Diabetes, which accounts for 16% of claims, is the next most active area.

By Nick Paul Taylor • March 2, 2023

AdvaMed unveils policy priorities with focus on breakthrough device coverage, global market access

Congress should also prioritize protecting the medtech manufacturing supply chain and enact diagnostic testing reform, the lobbying group said in releasing a set of nine policy goals.

By Susan Kelly • March 1, 2023

FDA authorizes first at-home flu-COVID-19 combination test days after its developer files for bankruptcy

Lucira filed for bankruptcy protection last week, saying the “protracted” authorization process caused it to miss out on test sales in the 2022 to 2023 flu season.

By Nick Paul Taylor • Feb. 27, 2023

Friday Q&A: GE HealthCare’s Yoder on using AI to drive precision care

The healthcare technology and diagnostics firm, now a standalone company, will integrate the acquisition of AI software developer Caption Health under Yoder’s lead.

By Susan Kelly • Feb. 23, 2023

Labcorp expects 2023 revenue growth, helped by Ascension testing agreement

The company’s business model is shifting as the diagnostics firm prepares to spin off its drug development business and expands management of hospital testing labs.

By Elise Reuter • Feb. 16, 2023

Baxter, Abbott, Thermo Fisher among medtech firms cutting jobs on supply issues, slide in testing

"What COVID gave to diagnostics companies, COVID taketh away now that the virus is endemic,” said one analyst.

By Susan Kelly • Updated Feb. 13, 2023

Illumina posts sales slump in Q4, bets on new sequencing machine to drive 2023 growth

Management is looking to the newly launched NovaSeq X system to help return the company to profitability this year.

By Nick Paul Taylor • Feb. 8, 2023

UK health system, under strain, lays out medtech strategy

The state-run National Health Service, now facing a strike by nurses and paramedics, hopes new technologies will help solve some of its long-term challenges to improve patient care.

By Susan Kelly • Feb. 7, 2023

Diagnostic firms turn to restructuring in bid to preserve cash: Goldman

The moves could lead to underfunding, delay or cancellation of research and development projects, the analysts say.

By Nick Paul Taylor • Feb. 7, 2023

Medtech earnings highlights: Easing of macro pressures, accelerated growth in 2023

Still, the latest round of quarterly results show that hospital staffing and supply chain remain a challenge.

By Nick Paul Taylor • Feb. 6, 2023

Quest cuts 2023 COVID tests forecast amid continued slump in demand; Q4 profit plunges

The company performed 1.2 million molecular tests in the fourth quarter, down from 1.9 million in the third quarter and 5.4 million one year ago.

By Nick Paul Taylor • Feb. 3, 2023

Friday Q&A: Medtronic’s Chan talks patient monitoring spinoff, rise of home care

As more patients are moved out of expensive hospital beds, Medtronic sees a growing market for remote care in homes and long-term care facilities.

By Elise Reuter • Feb. 2, 2023

BD raises full-year forecast, sees Q1 strength in pharmacy automation, pre-fillables

The company’s base businesses helped cushion the impact of declining COVID-19 testing demand.

By Susan Kelly • Feb. 2, 2023

Siemens Healthineers forecasts revenue growth to accelerate despite supply chain woes

Lower diagnostics revenue hurt sales in the three months ended Dec. 31.

By Nick Paul Taylor • Feb. 2, 2023

Medtech M&A outlook for 2023: Spinoffs, China exits, AI opportunities poised to spur deal rebound

Companies flush with cash are looking for good investments and innovative products that can reduce procedure costs, industry observers say.

By Peter Green • Jan. 31, 2023

Researchers create remote-controlled biological robot that could eventually be used in surgery

The design allows the integration of sensors and other components that could eventually equip the robots to detect biomarkers of disease, carry out biopsies or perform surgery.

By Nick Paul Taylor • Jan. 26, 2023

Abbott sees ‘signs of stability’ for 2023 as hospital staffing, supply chain improves

While the company continues to grapple with supply shortages and procedure restrictions, it sold more COVID-19 tests than expected in the fourth quarter.

By Elise Reuter • Jan. 25, 2023