Becton Dickinson to acquire Bard in $24B deal

Becton Dickinson (NYSE:BDX) has inked an agreement with C. R. Bard (NYSE:BCR) to acquire the medtech company for $317.00 per Bard common share in cash and stock, valuing the deal at $24 billion. In announcing the deal yesterday, Franklin Lakes, N.J.-based BD said it plans to create a new segment within the company, BD Interventional, to

Columbian regulators reduce medical device and IVD review timeframes

By Stewart Eisenhart, Emergo Group Medical device and in vitro diagnostic (IVD) market regulators in Colombia have pushed through changes to registration and modification processes with immediate effect. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those

Beaver-Visitec International to acquire Malosa Medical

Beaver-Visitec International – a developer, manufacturer, and marketer of specialized surgical devices for the ophthalmic marketplace– announced today that it has acquired Malosa Medical. Malosa Medical is a manufacturer and supplier of single-use surgical instruments, primarily for use in the field of ophthalmology. Additional terms of the transaction were not disclosed. “Fueled by an aging

Piezo Kinetics buys Channel Technologies Group’s ceramics division

Piezo Kinetics, a manufacturer of specialty piezoelectric ceramic elements and assemblies, has acquired Channel Technologies Group’s Ceramics Division assets, including all powder formulations and inventories of finished products. The Santa Barbara, Calif.–based ceramics subsidiary manufactures piezoelectric ceramics for the medical, energy, defense and commercial maritime industries. Financial terms of the cash acquisition were not disclosed. Piezo

The 10 hottest medtech startups of 2017

Medtech startups face more challenges than they have in the past, but several companies are developing products that take advantage of new technology and are specifically designed to meet healthcare’s evolving needs.    The number of medtech startups has declined. Thirty years ago, the medtech field averaged 1,500 startups; it slid to about 600 by

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Medtech stories we missed this week: April 21, 2017

From new and renewed partnerships to FDA approvals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses

23andMe is back: FDA allows marketing of genetic health risk tests

FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset Alzheimer’s disease. The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of

Malaysian combination product regulatory policy deadlines set

By Stewart Eisenhart, Emergo Group Malaysian medical device and drug market regulators have established a July 2018 implementation and enforcement deadline for combination product registrations marketed in the country. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect

GOP reportedly near completion of new healthcare bill – but support is split

Republican lawmakers are closing in on a new healthcare bill that would start dismantling and replacing Obamacare, according to a report from The Hill. Freedom Caucus chair Rep. Mark Meadows (R-N.C.) and moderate Tuesday Group co-chair Rep. Tom MacArther (R-N.J.) are brokering the compromised piece, according to the report. The revised plan would reportedly allow

Report: New FDA guidance release rate falls post-Trump election

The FDA hoped to release more than 100 draft guidance documents this year, but has only released 6 documents since Trump’s inauguration, according to a Regulatory Affairs Professional Society’s Regulatory Focus report. Since January 20, nearly 3 months ago, the agency has only released 2 guidance documents and 4 final guidances, according to the report.

4 top regulatory issues to watch in 2017

This is shaping up to be a big year when it comes to medtech regulation, as well as regulations for other types of life science companies. Rachel Beavins Tracy, EtQ This year is proving to have some big changes in store for life sciences companies. The new Trump administration brings changes in key areas such

Brexit effects on Authorized Representatives in EU and UK

By Ronald Boumans, Emergo Group On 29 March 2017, the United Kingdom’s ambassador to the European Union delivered a formal letter invoking Article 50 of the Treaty of the EU to the President of the European Council. This means the UK will leave the European Union in two years at the latest. The date of

Philips wins FDA authorization for digitized biopsied tissue slides

Philips recently received FDA permission to market its Philips IntelliSite Pathology Solution (PIPS) – touted as the first whole slide imaging system over which pathologists can review digital versions slides prepared from biopsied tissue. The FDA permission, which the agency announced April 12, marks the first time the agency has allowed the marketing of a

IMDRF wants to harmonize terminology for adverse event reporting

By Stewart Eisenhart, Emergo Group The International Medical Device Regulators Forum (IMDRF) has published a final draft of proposed terminologies for harmonized adverse event reporting for medical devices and IVDs. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily

What does FDA really mean when something is 510(k) exempt?

FDA undoubtedly provided some good news to the medical device industry last month when it proposed exempting hundreds of moderate-risk devices from 510(k) requirements. But don’t break out the champagne just yet if you happen to be developing a device that appears to be on the list. Even when the agency says a particular generic