FDA grappling with influx of illegal COVID-19 tests entering US

The agency has issued a flurry of recent warnings about diagnostics that have been illegally imported into the country as the demand for at-home coronavirus testing increased with the omicron surge.

By Greg Slabodkin • March 18, 2022

Illumina sues Guardant CEOs over trade secrets, sparking counterblast against 'retaliatory' lawsuit

Guardant called the lawsuit "frivolous and retaliatory" and framed it as a response to its concerns about the Illumina-Grail merger.

By Nick Paul Taylor • March 18, 2022

As White House warns of 'squandering' gains, AdvaMed sets out plan to sustain COVID-19 test capacity

The medtech lobby is calling for the creation of a permanent public-private diagnostic testing forum and warm-base manufacturing agreements to maintain testing capacity in the event of future surges. 

By Nick Paul Taylor • March 17, 2022

US replaces EU as priority market for medtech industry: survey

A survey of more than 100 executives at medical device companies found 89% of medtechs plan to prioritize U.S. regulatory approval going forward. One CEO said the EU's Medical Device Regulation "is killing innovation."

By Nick Paul Taylor • March 16, 2022

GE Healthcare profit forecasts meet estimates; spinoff details remain cloudy

While GE's planned spinoff of its healthcare unit in early 2023 remains on track, the company said business and regional segment details, stand-alone costs and capital structure have yet to be worked out.

By Greg Slabodkin • March 11, 2022

Celltrion recalls 1.2M rapid COVID-19 tests for improper labeling

The company initiated the fourth recall of its rapid COVID-19 tests in recent weeks, which the FDA designated as a Class II recall.

By Nick Paul Taylor • Updated March 9, 2022

HHS sets out plans to make medical device, diagnostics supply chains pandemic-proof

The U.S. Department of Health and Human Services wants to shore up the public health supply chain by investing in personal protective equipment, durable medical equipment and testing. 

By Nick Paul Taylor • Feb. 28, 2022

Roche's Foundation Medicine gets FDA breakthrough device nod in latest designations

Breakthrough status was granted to Foundation Medicine's test to detect molecular residual disease in early-stage cancer after curative therapy. A liquid biopsy from Datar Cancer Genetics was also given the regulatory privileges.

By Nick Paul Taylor • Feb. 25, 2022

Medtronic's Q3 revenue misses estimates as omicron curbs procedures

CEO Geoff Martha on Tuesday told investors the COVID-19 resurgence, which peaked in the final weeks of January, curbed procedure volumes. He expects them to recover in March and April.

By Greg Slabodkin • Feb. 22, 2022

Quidel expects COVID-19 test demand to continue through Q2, but offers no 2022 guidance

CEO Doug Bryant told investors Thursday that Quidel is seeing testing demand moderate in February, but the first quarter will result in the largest revenue in the company's history. The company did not provide full-year guidance.

By Greg Slabodkin • Feb. 18, 2022

EU issues guidance on high-risk IVDs, surveillance of legacy medical devices

The documents outline how notified bodies can meet In Vitro Diagnostic Medical Devices Regulation requirements to verify product batches of high-risk class D diagnostics, and manufacturer rules on quality management systems.

By Nick Paul Taylor • Feb. 17, 2022

Illumina continues to battle EU regulators over premature $8B Grail buy

CEO Francis deSouza told MedTech Dive that Illumina continues a two-front defense in the European Union — in the courts and with regulators — over its early acquisition of the cancer diagnostics test maker. 

By Greg Slabodkin • Feb. 16, 2022

Diagnostics M&A expected to be strong in 2022 after dealmaking took off last year

Respondents to KPMG's survey predict that deal volumes and values for the diagnostics space will jump again this year as companies are ready to spend more of their COVID-19 cash.

By Nick Paul Taylor • Feb. 16, 2022

Labcorp, Quest warn COVID-19 testing demand will plummet in 2022

The rival lab giants told investors during their latest earnings calls that they expect coronavirus-related test volumes to nose-dive by as much as 75%.

By Greg Slabodkin • Feb. 11, 2022

Ascension inks strategic relationship with Labcorp, expanding testing capabilities

Under the terms of the deal, Labcorp will manage Ascension's hospital-based laboratories in 10 states, and acquire select assets of the St. Louis-based system's outreach laboratory business.

By Rebecca Pifer • Feb. 10, 2022

BioCardia, Cook Medical land FDA breakthrough nods in latest designations

Cardiovascular devices feature prominently in the tech granted regulatory privileges, including a drug-eluting stent for patients with chronic limb-threatening ischemia and a non-invasive cardiac monitoring device. 

By Nick Paul Taylor • Feb. 9, 2022

Guardant Health targets colorectal cancer screening in 2022

CEO Helmy Eltoukhy tells MedTech Dive the precision oncology company plans to launch a liquid biopsy in the first half of the year, rivaling Exact Sciences' Cologuard stool test.

By Greg Slabodkin • Feb. 8, 2022

Roche partner recalls illegally imported rapid COVID-19 tests from US

FDA said there are "confirmed reports" of unlawful importation of the Standard Q COVID-19 Ag Home Test and South Korea's SD Biosensor is looking into which distributors or people were involved.

By Nick Paul Taylor • Feb. 7, 2022

CDRH targets hiring, novel approvals among 2022-2025 strategic priorities

FDA's Center for Devices and Radiological Health, whose staff continues to struggle with an unprecedented workload since the pandemic's start, is aiming to achieve at least 90% of its annual hiring targets for certain years.

By Nick Paul Taylor • Feb. 4, 2022

BD's Q1 revenue beats Street despite COVID-19 testing decline

In spite of the pandemic and macroeconomic challenges, CEO Tom Polen said the company has "confidence" to raise 2022 revenue guidance "while remaining appropriately prudent, given the current uncertain environment." 

By Greg Slabodkin • Feb. 3, 2022

Thermo Fisher, Hologic plan for extended test demand in 2022

In a year of ups and downs for COVID-19 testing, both companies are raising revenue guidance for 2022 as the need for diagnostics isn't fading.

By Elise Reuter • Feb. 3, 2022

Siemens Healthineers ups 2022 forecast after COVID-19 test boom, but sees increased competition

CFO Jochen Schmitz told investors Thursday that as competition in the diagnostics space heats up this year, the company expects "revenues to decline sharply in the second half."

By Nick Paul Taylor • Feb. 3, 2022

Breakthrough device program 'far exceeding' FDA expectations after record year

The total number of products granted the agency's regulatory privileges in 2021 increased by more than 50%, while the number of novel devices that came to market fell compared to 2020.

By Nick Paul Taylor • Feb. 1, 2022

3 key FDA topics for medtechs in 2022

While the agency is looking to get back to normal operations this year, COVID-19 is poised to remain a top priority and, once again, thin resources for more traditional work, such as product reviews.

By Ricky Zipp , Greg Slabodkin • Feb. 1, 2022

Roundup: Latest earnings show medtechs grappling with healthcare staffing shortages, supply chain

Medical device companies ended 2021 on an "uninspiring" note, J.P. Morgan analysts said, as they brace for a slowdown in procedures driven by a surge in COVID-19 cases due to the omicron variant.

By Elise Reuter • Jan. 31, 2022