Digital health, heart disease devices feature in latest FDA breakthrough designations

Philips, Endologix and several smaller companies in recent weeks won the regulatory privilege, giving them speedier review of products that may provide more effective treatments for life-threatening conditions.

By Nick Paul Taylor • Aug. 2, 2021

Siemens Healthineers' diagnostic sales soar on EU demand for COVID-19 tests

Antigen test revenue grew more than 200% but is now expected to drop significantly. Unlike rivals Abbott and Quidel, which have seen fast-falling sales, the German medtech primarily serves Europe.

By Nick Paul Taylor • July 30, 2021

Explore the Trendline➔

New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Thermo Fisher slashes COVID-19 testing guidance by $900M

Following peers like Abbott and Quidel, execs expect test demand to slow for the rest of the year. CFO Stephen Williamson called it "prudent" to "de-risk the outlook" for testing.

By Greg Slabodkin • July 28, 2021

Quidel to transfer heart failure assay to Beckman Coulter to end litigation

While analysts at Craig-Hallum and William Blair said that they thought Quidel had a solid legal case, the agreement eliminates the remaining risk.

By Nick Paul Taylor • July 27, 2021

GE Healthcare's COVID-19 recovery continues with double-digit growth in imaging, ultrasound

Second-quarter results reflect the return of elective procedures to pre-pandemic levels. A standout was its pharmaceutical diagnostics business which saw orders grow nearly 50% organically year over year.   

By Greg Slabodkin • July 27, 2021

PerkinElmer inks $5.3B takeover of antibody provider BioLegend

Flush with revenue from COVID-19 testing, the medtech is betting the company can sustain a high growth rate amid competition from BD and Thermo Fisher.

By Nick Paul Taylor • July 27, 2021

Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery

CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.

By Nick Paul Taylor • July 26, 2021

Illumina-Grail merger subject of in-depth EU antitrust probe

European officials opened a three-month investigation of the deal, valued up to $8 billion, due to concerns it may reduce competition in the emerging liquid biopsy market. Illumina vowed to press on.

By Nick Paul Taylor • July 23, 2021

Abbott latest to report pandemic recovery in Q2 as procedures return, COVID-19 tests drag diagnostics

While growth was positive across the four major businesses, coronavirus test sales came in at $1.3 billion, far below the $2.2 billion reported in the previous quarter, though ahead of lowered expectations.

By Greg Slabodkin • July 22, 2021

FDA seeks funds, powers to fix 'great weaknesses' in medical device supply chain

Acting FDA Commissioner Janet Woodcock wants Congress to give the agency "expanded authority to obtain supply disruption notifications for critical devices any time there is the potential for a shortage."

By Nick Paul Taylor • July 22, 2021

PacBio inks $800M Omniome buyout to expand into short-read sequencing

The acquisition will give Pacific Biosciences access to early-stage cancer screening and recurrence monitoring markets. The bid comes 18 months after Illumina scrapped plans to acquire PacBio amid regulatory pushback.

By Nick Paul Taylor • July 21, 2021

Abbott, Intuitive and J&J kick off medtech earnings as COVID-19 bellwethers

Intuitive and J&J are set to report results this week that will shed light on the recovery of elective procedures, while Abbott will provide insights into the drop in coronavirus test demand.

By Nick Paul Taylor • July 19, 2021

FDA grants Curative request to revoke COVID-19 test EUA, company pivots to Abbott kits after false result risk

The agency, which announced the revocation on Thursday, originally granted an emergency use authorization to Curative's test in April 2020. By January, FDA had concerns about false results potentially linked to sample collection.

By Nick Paul Taylor • July 16, 2021

Qiagen joins Abbott, Quidel cutting 2021 outlook as COVID-19 test demand wanes

CEO Thierry Bernard blamed a faster-than-expected testing drop and uptick of vaccinations. Jefferies said the downgraded targets are disappointing, particularly given management's forecast reiteration last month.

By Greg Slabodkin • July 13, 2021

MDUFA talks expose 'fundamentally different' views of FDA and device companies

At the latest meeting over user fees, industry remained opposed to the agency's pitch for a Total Product Life Cycle Advisory Program, which it contends would extend the scope beyond FDA's purview. 

By Nick Paul Taylor • July 12, 2021

Abbott lays off 400 workers amid drop in demand for COVID-19 tests

The company cut its 2021 outlook in June, blaming a sharp, rapid decline in demand for its coronavirus-related diagnostics on global vaccination efforts. The downward trend is anticipated to continue, an Abbott spokesperson said. 

By Greg Slabodkin • July 9, 2021

Quidel COVID-19 PCR recall dubbed Class I by FDA due to false negative risk

The diagnostic company said it worked with FDA to confirm "a rare potential" for false test results and that the notice alerts lab customers of label changes made two months ago with no products removed from shelves.

By Nick Paul Taylor • Updated July 9, 2021

As EU-wide health technology oversight law nears passage, industry is not pleased

If passed, the legislation mandates European Union clinical assessments of certain medical devices to inform national-level pricing and reimbursement decisions.

By Nick Paul Taylor • July 6, 2021

Neuromodulation and cancer devices feature in latest batch of FDA breakthrough nods

Neuroelectrics, Neuros Medical and Onward are among those that secured the regulatory privilege, which speeds the review process for unmet medical needs.

By Nick Paul Taylor • July 2, 2021

PMA apps could hit record in 2021, pressuring a pandemic-stressed FDA

Despite increased workloads from the coronavirus crisis, the agency is also on track to issue record numbers of safety warnings and letters to healthcare providers in 2021, according to a Wells Fargo analysis.

By Nick Paul Taylor • July 2, 2021

COVID-19 antigen testing on par with PCR when used often: NIH-funded study

The two diagnostic methods were equally effective in detecting SARS-CoV-2 infection. The results could be good news for antigen test makers Abbott, Becton Dickinson and Quidel.   

By Greg Slabodkin • July 1, 2021

Abbott gets CE mark to sell COVID-19 antigen test directly to consumers in Europe

The company's rapid Panbio diagnostic received the marking in January for asymptomatic coronavirus screening. However, the test missed half of COVID-19 cases in people without symptoms, according to a recent Irish study.  

By Greg Slabodkin • June 28, 2021

Lawmakers reintroduce diagnostic regulation bill that split the industry

The VALID Act would create a risk-based regulatory framework for in vitro diagnostics and laboratory-developed tests. ACLA, whose members include Quest and LabCorp, is reviewing the bill but has objected to earlier drafts.

By Nick Paul Taylor • June 25, 2021

EU clarifies Eudamed rules for legacy and custom-made devices

The Medical Device Coordination Group has provided information on products placed on the market under frameworks other than MDR and IVDR, which the advisers said should be registered in the database.

By Nick Paul Taylor • June 25, 2021

PerkinElmer, Qiagen latest medtechs to target rapidly growing CRISPR market

Qiagen launched new products to enable researchers to better analyze the gene editing impact of their work, while PerkinElmer bought viral vector gene delivery company SIRION Biotech to complement its CRISPR portfolio.  

By Greg Slabodkin • June 23, 2021