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Federal COVID-19 aid fueled huge jump in national health spending last year

The pandemic accounted for major changes in who paid for healthcare as job losses spurred changes in coverage types, while people deferred care and spent less out of their own pockets.

Medtronic's Covidien initiates ventilator recall due to manufacturing error

Puritan Bennet 980 series ventilators can become inoperable during use, according to the FDA recall database. The agency labeled the recall a Class I event, the third such classification for the product since 2015.

Updated Dec. 14, 2021

Roundup: Baxter completes $10.5B Hillrom acquisition

Wall Street analysts have questioned the price and strategic fit of the deal, which is the largest medtech buy so far in 2021.

Flurry of doctor group buyouts helps fuel 'extraordinary' surge in health M&A

Companies across the healthcare spectrum are pursuing deals to strengthen operations after two years of pandemic-driven challenges, a PwC report found.

NuVasive's scoliosis system gets reinstated CE mark, new instructions for use

FDA said in a Friday safety communication that NuVasive has also lifted a shipping hold for MAGEC systems outside of the U.S. The company lifted a U.S. shipping hold in July.

Updated Dec. 13, 2021

FDA seeks comment on 3D printing of medical devices at hospitals, doctor's offices

The agency's discussion paper lays out the benefits and challenges of creating 3D-printed devices in healthcare settings as well as a potential approach for regulatory oversight.

Neurostimulator to treat stroke fails to gain FDA advisory panel support

The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study.

Senate passes bill to delay 2022 Medicare rate cuts for hundreds of lab tests

Senators late Thursday passed an end-of-year package that will delay the 15% cuts for nearly 600 tests slated to kick in next month. Passed by the House on Tuesday, the bill must still be signed by President Joe Biden to become law.

Updated Dec. 10, 2021

Senate passes legislation to avoid Medicare cuts for providers in year-end sprint

Groups like the American Hospital Association came out in support of the legislation, which would mitigate some of the cuts set to soon take effect.

Updated Dec. 10, 2021

Edwards sees double-digit 2022 sales growth boosted by another TAVR jump

The cardiac device maker estimated 12% to 15% growth next year for transcatheter aortic valve procedures. During its annual investor conference, Edwards also updated future growth projections for key markets.

FDA floats independent contractor to track MDUFA hiring following medtech pressure

The agency made the offer during the Medical Device User Fee Amendments V meetings in response to industry negotiators who want a clearer picture of how the program uses the money it receives.

Study finds surgery volumes bounced back after 2020 COVID-19 shutdown, confirming medtech sales trends

Confounding factors such as healthcare staffing shortages caused the delta variant headwind to drag on — and, now, rapidly increasing inpatient volumes are leading U.S. hospitals to once again delay surgical procedures.

Implantable cardioverter defibrillators are underused in women, racial minorities: study

The proportion of people who received an ICD rose from 11.6% in 2003 to 17% in 2014, according to the Mayo Clinic study. However, that overall figure masks differences between patient groups.

Tandem Diabetes Care targets 1M customers by 2027

The insulin pump maker expects to triple its installed units over the next five years behind new product launches and capturing market share as use among Type 1 and Type 2 patients is projected to take off.

Study links cochlear implants to new bone formation, long-term residual hearing loss

Ultra-high spatial resolution CT detected new bone formation in two-thirds of the patients within four years of implantation, which adversely affected their long-term hearing preservation, according to a study in the journal Radiology.

Insulet Omnipod 5 insulin pump clearance delayed to 2022: CEO

Although news of a delay for the anticipated pump pressured the company's shares Friday, analysts remained upbeat on the device's long-term prospects.

Thermo Fisher, Verily on FDA list of COVID-19 tests affected by omicron variant

The agency's list focuses on coronavirus diagnostics impacted by S-gene dropout, an occurrence that is most commonly associated with Thermo Fisher Scientific's TaqPath test kits.

Cancer treatments lead latest FDA breakthrough device designations

The agency granted regulatory privileges to therapies for lung cancer and bone metastases from RefleXion Medical and Zetagen Therapeutics, respectively.

Biden orders private health insurers to cover COVID-19 home tests

Test makers such as Abbott, BD and Quidel could see demand increase as costs for consumers are reimbursable. The White House is also doubling distribution of free at-home tests to uninsured and underserved communities.

Congress passes on delay to Medicare rate cuts for lab tests, for now

The American Clinical Laboratory Association wants lawmakers to push off 2022 cuts for nearly 600 lab tests. A stopgap bill late last week did not include a reprieve, but Cowen analysts are optimistic a legislative fix will be found.

Device recalls jumped 36% in Q3, first quarterly increase since 2020: report

The primary reasons for recalls in the quarter were software issues, which have been the leading causes in 21 of the last 22 quarters, according to Sedgwick's November U.S. product recall index.

Medicare telehealth visits increased 63-fold from 2019 to 2020, new government data shows

Virtual visits for Medicare beneficiaries went from hundreds of thousands pre-pandemic to tens of millions in 2020, with many beneficiaries using telehealth for the first time.

Medical device security continues to be casualty of hospital-medtech divide

FDA says manufacturers and hospitals are both responsible for protecting devices from growing cybersecurity threats. However, experts say healthcare providers carry a much heavier load.

EU finalizes implementing regulation for Eudamed medical device database

The European Commission has provided a framework for the basic operation of the system, slated for a May 2022 launch, including how to access it, what it will do in the event of a database malfunction and IT security measures.

NuVasive resumes US shipments of titanium-based orthopaedic devices, gets FDA thumbs up

The agency voiced its support for the reintroduction of the Precice products, telling healthcare providers that the availability of the devices is in the best interests of patients as the benefits outweigh the known risks.