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

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

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

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