CMS implementation of breakthrough payment rule may be further delayed: Cowen

The agency will most likely push the start date back further to address the concerns of critics of the contentious Medicare Coverage of Innovative Technology initiative, an analyst contends.

By Nick Paul Taylor • May 10, 2021

Quidel says COVID-19 testing 'not forecastable' as it targets alternative, at-home markets

CEO Doug Bryant on Thursday's first-quarter earnings call said the company sees increasing revenue opportunities tied to at-home, back-to-school and back-to-work tests but "it's impossible for us to model at this stage."

By Greg Slabodkin • May 7, 2021

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

NeoGenomics inks $390M Inivata buyout to enter liquid biopsy space

William Blair analysts wrote that NeoGenomics got a good price by setting the buyout fee last year.

By Nick Paul Taylor • May 6, 2021

BD grows Q2 revenue despite COVID-19 test dip, spins off diabetes business

The spin off for the separate publicly traded company is expected to be completed in the first half of calendar year 2022. The move will not impact BD's ability to fulfill orders related to COVID-19 vaccinations, execs said.

By Greg Slabodkin • May 6, 2021

AI, digital health feature in latest batch of FDA breakthrough device designations

The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.

By Nick Paul Taylor • May 5, 2021

Qiagen braces for COVID-19 testing volatility as sales hold steady in Q1

Coronavirus-related revenues were flat sequentially, helping the company to grow above its outlook. However, the consistency masks changes in where tests are in demand with region-to-region variability expected to continue.

By Nick Paul Taylor • May 4, 2021

LabCorp inks $150M takeover of Myriad Genetics autoimmune testing unit

The diagnostics giant discussed its interest in M&A last week, outlining plans to use up to $2 billion in free cash flow to strengthen its businesses through acquisitions.

By Nick Paul Taylor • May 4, 2021

Siemens raises outlook as COVID-19 antigen tests blast past original sales target

The company's bullish prospect for its rapid antigen test business comes as rivals like Abbott Laboratories and Quidel, which are more exposed to the U.S. market, fell short of expectations in the first quarter.

By Nick Paul Taylor • May 3, 2021

Illumina sues European Commission to block competition probe into Grail buyout

The EU probe is the latest glitch in the takeover bid, which was panned by Wall Street and also faces scrutiny from the FTC. Analysts have said Exact Sciences could benefit from delays.

By Nick Paul Taylor • April 30, 2021

Hologic, Thermo Fisher cautious on COVID-19 test demand as vaccines roll out

Hologic CEO Stephen MacMillan told investors late Wednesday demand has fallen significantly since January amid vaccinations. Both companies expect recent M&A to be a crucial part of post-pandemic strategies.

By Greg Slabodkin • April 29, 2021

CMS pitches extra year of add-on payments for Boston Scientific, Stryker, other devices

Boston Scientific's Eluvia drug-eluting stent, Cook Medical's Hemospray and Stryker's SpineJack system are among those that would get the extension under the proposed fiscal 2022 inpatient hospital rule.

By Nick Paul Taylor • April 28, 2021

Abbott, Quest look to post-pandemic home testing beyond COVID-19

With development of at-home coronavirus tests, the companies see opportunities for over-the-counter and direct-to-consumer diagnostics for other diseases and conditions, from respiratory ailments to cancer.

By Greg Slabodkin • April 27, 2021

GE Healthcare grows sales as routine screening, elective procedures return

The results provide further evidence that the resumption of elective procedures has driven up demand for imaging and other healthcare products and services. GE saw volumes return for cardiac, oncology and neurology screening.

By Nick Paul Taylor • April 27, 2021

Quidel shakes Wall Street with bearish COVID-19 test forecast

The company late Thursday pre-announced first-quarter revenue nearly $100 million below analyst expectations, with Craig-Hallum's Alex Nowak now calling the business unforecastable.

By Greg Slabodkin • April 23, 2021

Science groups urge caution against using certain COVID-19 test data

The Association for Molecular Pathology and the Infectious Diseases Society of America say relying on cycle threshold (Ct) values runs the risk of being misinterpreted due to a lack of standardization across test methods.

By Susan Kelly • April 23, 2021

Quest Q1 revenue jumps 49% even as COVID-19 test demand wanes

CEO Steve Rusckowski told investors Thursday the lab giant's routine business continued its recovery to near pre-pandemic levels, helping offset coronavirus diagnostics coming in below estimates.

By Greg Slabodkin • April 22, 2021

Roundup: Medtech earnings show early signs of electives return, lingering testing uncertainty

The industry is reporting an elective care rebound in March after volumes dropped in the winter, while COVID-19 test demand appears to be softening as vaccination numbers grow.

April 22, 2021

Roche sees strong Q1 sales in COVID-19 tests, routine diagnostics

Roche Diagnostics CEO Thomas Schinecker predicted second-quarter coronavirus sales would also be healthy, continuing into the third quarter.

By Greg Slabodkin • April 21, 2021

Abbott misses Wall Street as COVID-19 test sales softer than expected

CEO Robert Ford told investors on Tuesday that $1.8 billion in sales were from its rapid coronavirus testing platforms as he sees a shift to surveillance. But he acknowledged testing is "difficult to forecast right now." 

By Greg Slabodkin • April 20, 2021

FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan

The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.

By Nick Paul Taylor • April 16, 2021

Thermo Fisher to buy research contractor PPD for $17.4B

The deal comes months after a failed attempt by the company to acquire molecular diagnostics company Qiagen. 

By Kristin Jensen • April 15, 2021

6 medtechs to watch when earnings kick off next week

First quarter results from Abbott, Edwards, Intuitive, J&J, Quest and Roche will help reveal the pace of procedure recovery and if the coronavirus testing boom has legs despite the rollout of vaccines. 

By Nick Paul Taylor • April 15, 2021

Mid-sized medtechs hit hardest by pandemic, though sector seen resilient: poll

The survey of more than 1,600 industry professionals from Emergo by UL also found respondents are most bullish on tapping Asian markets.

By Nick Paul Taylor • April 14, 2021

Lucira gets FDA nod for OTC molecular COVID-19 test

The emergency authorization adds to the competition with the agency clearing over-the-counter tests from Abbott and Cue Health in recent months. The $55 per kit price tag is much higher than Lucira's estimate earlier this year.

By Nick Paul Taylor • April 13, 2021

Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance

The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions. 

By Greg Slabodkin • April 12, 2021