Cue, Google's COVID-19 test provider, raises $200M in IPO

The at-home test maker will use the money to scale up commercial and manufacturing infrastructure to support its portable diagnostic platform. Cue Health's Friday debut on the Nasdaq valued the company at $2.9 billion.

By Nick Paul Taylor • Sept. 27, 2021

Quarter of providers saw mortality rates rise after ransomware attacks, survey finds

Only 36% of healthcare organizations said they are effective in knowing where all their medical devices are, while just 35% indicated they know when a device's operating system is at end of life or out of date.

By Rebecca Pifer • Sept. 24, 2021

Medtechs face supply chain disruptions from semiconductor shortage: report

The AdvaMed-commissioned survey found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year.

By Nick Paul Taylor • Sept. 24, 2021

FDA tells COVID-19 test makers to assess impact of variants in new EUA conditions

The agency's order to assess performance comes amid renewed focus on testing that's seen manufacturers add capacity and land contracts with the federal government worth more than $1 billion.

By Nick Paul Taylor • Sept. 24, 2021

Boston Scientific CEO: 'Unprecedented' shutdown from delta to hit Q3

CEO Michael Mahoney cited a six- to seven-week impact from the variant beginning in August, in line with other warnings from medtechs. He said meeting full-year sales estimates is "still possible."

By Ricky Zipp • Sept. 23, 2021

Thermo Fisher COVID-19 testing forecast tops estimates, crushes 2022 guidance

The estimated $750 million in sales versus $365 million predicted by analysts comes amid the surge of the delta variant.

By Nick Paul Taylor • Sept. 20, 2021

FDA warns of false positive risk of Abbott COVID-19 lab tests

CEO Robert Ford called rollout of the analyzer connected to the tests as a growth driver for the diagnostics business in July.

By Nick Paul Taylor • Sept. 20, 2021

FDA policy in response to COVID-19 offers blueprint for regulation of LDTs: study

The agency's response to the pandemic showed it can oversee lab-developed tests, according to Massachusetts General Hospital researchers. They contend that their study could inform legislation aimed at regulating such diagnostics.

By Nick Paul Taylor • Sept. 17, 2021

FTC warns app makers fall under breach notification rule

The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.

By Shannon Muchmore • Sept. 16, 2021

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

Delta patients clog hospitals, spur more procedure delays

Intermountain is the latest system to announce it's postponing elective procedures starting Wednesday at 13 of its hospitals, and expects the pause to last several weeks, CEO Marc Harrison said Friday.

By Hailey Mensik • Sept. 15, 2021

Zimmer latest medtech to warn of delta wave drag in Q3

The company cautioned that delta variant pressures could extend into the fourth quarter. Despite the warning of the impact on the business, Zimmer's stock price was up nearly 5% Tuesday.

By Nick Paul Taylor • Sept. 15, 2021

NuVasive warns of delta hit in Q3 as hospitals once again limit electives

The company's update offers another early indicator that medtechs will likely be hit in the third quarter due to delta variant surges.

By Nick Paul Taylor • Sept. 14, 2021

Jefferies lowers medtech outlooks as hospitals project delta pressure into Q4

The investment bank lowered its third quarter outlook for medical device companies with revenues heavily based on surgical volumes, including Boston Scientific, Medtronic and Stryker.

By Rebecca Pifer • 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

Humana reports dip in non-COVID-19 Medicare Advantage admissions amid delta surge

The payer also expects outpatient visits to contract, a trend seen in prior waves of the pandemic.

By Samantha Liss • Sept. 9, 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

ECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb

Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.

By Ricky Zipp • Sept. 3, 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

Baxter's $10.5B Hillrom buy on track, deal to close by early 2022: CEO

Baxter CEO Joe Almeida said the standard U.S. antitrust waiting period expired with no second FTC information request. Other global regulatory hurdles remain and shareholders are set to vote on the deal on Dec. 2.

By Greg Slabodkin • Updated Oct. 28, 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

FDA restarts distribution of Lilly's COVID-19 drug in 22 states

Use of the treatment had been halted due to weakened efficacy versus an early coronavirus variant. Now, with delta widely prevalent and demand for antibody treatments surging, Lilly's therapy will be available again. 

By Shoshana Dubnow • Aug. 31, 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

Medtechs made it out of Q2 with minimal impact from delta. That could change in Q3.

After procedure-dependent medtechs reported strong elective returns in the first half of 2021, the delta variant is now posing a risk to the industry's recovery as hospitals once again shut down procedures.

By Ricky Zipp • Aug. 26, 2021

Hospital volume recovery on shaky ground amid delta, Kaufman Hall reports

Outpatient revenue fell in July, suggesting patients might again be delaying non-urgent care. The survey comes as elective dependent medtechs navigate the latest wave of the variant sweeping much of the South.

By Hailey Mensik • Aug. 25, 2021