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

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

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

Boston Scientific, Stryker get extra year of add-on payments as CMS adjusts to pandemic

Comments "overwhelmingly supported" the plan to use pre-pandemic data on the cost of inpatient stays to inform CMS' rates for fiscal 2022.

By Nick Paul Taylor • Aug. 3, 2021

Abbott's Alere to pay DOJ $160M in Medicare mail-in diabetes test false claims settlement

An Abbott spokesperson in an emailed statement noted the issue "relates to alleged activities that took place prior to Abbott's acquisition" and was earlier disclosed in financial filings. 

By Greg Slabodkin • Aug. 3, 2021

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

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