FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions

The agency's order to assess performance comes amid renewed focus on testing that's seen manufacturers add capacity and land contracts with the federal government worth more than $1 billion.

By Nick Paul Taylor • Sept. 24, 2021

GE Healthcare to buy BK Medical for $1.45B

The deal is aimed at expansion beyond diagnostics into surgical and therapeutic interventions, with high-single-digit return on invested capital anticipated by year five, CEO Kieran Murphy said.

By Greg Slabodkin • Sept. 23, 2021

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

EU threatens Illumina for closing $8B Grail deal while still under review

The European Commission's warning of fines and other measures is another step in a saga that could run for years. If the bloc ultimately opposes the acquisition, the path forward will be through the courts.

By Nick Paul Taylor • Sept. 22, 2021

Paige's AI-based software gets FDA nod to help doctors identify prostate cancer

It's the latest in a series of milestones for the startup, which has picked up 510(k) clearance for its image viewer, raised more than $220 million and partnered with Philips and Quest Diagnostics in recent years.

By Nick Paul Taylor • Sept. 22, 2021

Thermo Fisher COVID-19 testing forecast tops estimates, crushes 2022 guidance

The estimated $750 million in sales versus $365 million predicted by analysts comes amid the surge of the delta variant.

By Nick Paul Taylor • Sept. 20, 2021

FDA warns of false positive risk of Abbott COVID-19 lab tests

CEO Robert Ford called rollout of the analyzer connected to the tests as a growth driver for the diagnostics business in July.

By Nick Paul Taylor • Sept. 20, 2021

FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study

The agency's response to the pandemic showed it can oversee lab-developed tests, according to Massachusetts General Hospital researchers. They contend that their study could inform legislation aimed at regulating such diagnostics.

By Nick Paul Taylor • Sept. 17, 2021

Hong Kong-based Prenetics to go public in US as part of $1.25B SPAC merger

Prenetics, which is set to pocket $459 million through the deal, will use the money to step up its attack on markets targeted by companies including 23andMe, Exact Sciences and Invitae.

By Nick Paul Taylor • Sept. 16, 2021

CMS moves to scrap MCIT rule due to clinical evidence concerns

AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation. 

By Nick Paul Taylor • Sept. 14, 2021

MedTech Europe calls for urgent clarification of EU artificial intelligence proposal

The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.

By Nick Paul Taylor • Sept. 13, 2021

Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push

Using the Defense Production Act, the White House will push for expanded test production, with $2 billion earmarked to buy nearly 300 million rapid antigen tests for schools, health centers and food banks.  

By Greg Slabodkin • Sept. 10, 2021

FDA ends summer with fresh batch of breakthrough device designations

Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.

By Nick Paul Taylor • Sept. 10, 2021

Jennifer Doudna-founded CRISPR biotech raises cash to move beyond diagnostics

Mammoth gained recognition earlier this year by developing a test for COVID-19 based on CRISPR science.

By Shoshana Dubnow • Sept. 9, 2021

EU expert panel starts accepting applications to review high-risk IVDs

The incoming IVD regulation, set to go into effect next May, requires certain diagnostics be reviewed by the committee and/or tested by a reference lab.

By Nick Paul Taylor • Sept. 7, 2021

Abbott, Quest, Quidel scramble to add test capacity as delta variant surges

Quest Diagnostics is adding testing platforms in areas of the U.S. with high demand while manufacturers of at-home coronavirus tests such as Abbott and Quidel are ramping up capacity again after the early summer slump.

By Nick Paul Taylor • Sept. 3, 2021

Cancer diagnoses stayed low even as initial COVID-19 crisis eased: Quest

Researchers warn cancers may continue to go undetected leading to a wave of patients with advanced stages of disease.

By Nick Paul Taylor • Sept. 1, 2021

BD gets emergency FDA nod for smartphone-enabled COVID-19 test

The medtech is launching the product against a backdrop of rising demand for similar diagnostics, as the delta wave spurs a surge in cases nationwide after a pullback in the first part of the year.

By Nick Paul Taylor • Aug. 27, 2021

EU builds out MDR, IVDR guidance ahead of flurry of implementing acts

The European Commission has advice on notified bodies, quality management systems and COVID-19 tests, among other topics, as medtechs work to comply with the new and looming regulations.

By Nick Paul Taylor • Aug. 24, 2021

SPAC slashes value of LumiraDx merger by $2B on falling COVID-19 testing forecast

LumiraDx recently halved its full-year sales guidance after being buffeted by the same forces rocking larger COVID-19 test providers such as Abbott and Quidel.

By Nick Paul Taylor • Aug. 23, 2021

Biden said to rule out Woodcock as permanent FDA chief

A published report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving it unfilled seven months into President Joe Biden's term.

By Jonathan Gardner • Aug. 20, 2021

EU launches probe of Illumina decision to close Grail deal despite ongoing investigation

If the European Commission finds that Illumina breached a "standstill obligation" rule as part of this latest probe, the company could be fined up to 10% of its revenue.

By Nick Paul Taylor • Updated Aug. 20, 2021

Abiomed leads latest FDA breakthrough designations for heart disease devices

The agency awarded the breakthrough privileges to Abiomed's Impella ECP, which the company contends is the world's smallest heart pump and could provide critical hemodynamic support to coronary artery disease patients.

By Nick Paul Taylor • Aug. 19, 2021

Amid delta surge, Thermo Fisher EUA for COVID-19 assays seeks to compensate for variants

FDA in January said accuracy of PCR tests from Thermo Fisher and others may be affected by variants. Testing chief Tim Stenzel said the agency is working to ensure EUA-authorized tests are still performing amid virus mutations.

By Greg Slabodkin • Aug. 16, 2021

BD results called mixed amid bullish COVID-19 testing outlook

The medtech assumes no major system-wide hospital restrictions on electives, despite the rapid spread of the delta variant, raising eyebrows from one analyst group. BD also announced CFO Chris Reidy will retire.

By Greg Slabodkin • Aug. 5, 2021

Roundup: Medtechs mirror pre-pandemic results in Q2 fueled by procedure volume recovery

After elective procedures began gradually rebounding in the first quarter of 2021, companies are reporting results close to or beating 2019 levels.

Aug. 3, 2021