Webinar: The top medtech stories of 2017 – Jan. 30

Tuesday, January 30, 2018 2:00pm ET / 11:00 PT     The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. MDO’s managing editor Chris Newmarker will

Report slams European Union’s high-risk medical device approvals rate

A health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR. The authors looked at 1,376 health technology assessment (HTA) reports filed between 2010 and 2015.

Medical device startups: Here’s how you successfully plan

The development of the product development plan is an evolutionary effort that continues through the life of the medical device project. Bill Betten, Betten Systems Solutions, and Tom Waddell, Waddell Group This is the second in a series of articles that will discuss the design of innovative products in the highly regulated medical environment.  The

FDA refines least burdensome guidance for medical device oversight

Stewart Eisenhart, Emergo Group Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants. 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 of MedicalDesignandOutsourcing.com

The medical device tax is back in effect

The ringing in of the new year also rang in the return of the medical device tax, a 2.3% levy on medtech sales that went back into effect after a two-year pause. The U.S. Congress closed out 2017 without taking action to delay or repeal the medtech tax, despite broad support from both sides of the […]

What is the future of medtech in 2018?

Some of the largest medtech companies showed in 2017 that they are ready to grow through embrace of the new healthcare ecosystem. Medical device companies are putting greater emphasis on value-based arguments for their products and services. They’re putting more attention to clinical and economic research and adopting digital products that incorporate machine learning and

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Upcoming changes to FDA electronic medical device reporting in 2018

Registrar Corp. Medical device manufacturers and importers are required to report “adverse events” to FDA when their device has caused or contributed to death or serious injury.  An adverse event is when a device has a malfunction that could cause death or serious injury.  Importers report this information to the manufacturer.  The FDA has announced

Medtech stories we missed this week: Dec. 29, 2017

From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning. 1. NanoVibronix inks deal with Indian regulatory and distribution consultant NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory

BD closes $24B Bard buy-out

Becton Dickinson & Co. (NYSE:BDX) said today that it completed its buy-out of C.R. Bard (NYSE:BCR). The combined company boasts $16 million in yearly revenue. The $317-per-share deal was first announced in April and in the past few months won conditional approval in the E.U., the U.S. and China. “Today is a historic day for BD as […]

7 top stories that mattered for medtech in 2017

The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. Here are seven stories that mattered for the medical device industry this year. Next>>

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FDA clears device that treats diabetic foot ulcers for market

The FDA announced today that it has cleared the Dermapace System diabetic foot ulcer treatment device for market. Dermapace System is the first shockwave device to treat foot ulcers caused by diabetes, according to the device’s creator Sanuwave. “Diabetes is the leading cause of lower limb amputations,” Binita Ashar, director of the division of surgical

Report: Korea to adopt ‘fast-track’ approval for next-gen med devices

South Korea’s regulatory bodies have agreed to adopt a “fast-track” approval process for next-generation medical devices, according to a new report from the Korea Herald. The policies are being enacted to promote medical devices whose success is dependent upon entering the market ahead of their competitors, and would allow devices to be certified on a […]

Beta Bionics raises $2m

Beta Bionics has raised $2.4 million in a new round of equity and securities financing, according to an SEC filing posted this week. A total of 11 anonymous investors have participated in the round, though the company has not yet stated who has joined or how it plans to spend funds raised. Read the whole […]

Nanobiotix’s nanoparticle-immunotherapy trial wins FDA approval

Nanobiotix (EMA:NANO) said today that the FDA has approved its IND application for a cancer trial combining its radiotherapy-activated nanoparticle tech with an anti-PD1 antibody. The Phase I/II trial is slated to evaluate the safety and efficacy of Nanobiotix’s NBTXR3 product administered with checkpoint inhibitors in three groups of patients with recurrent or metastatic head and neck […]

FDA proposes easing of medical device malfunctioning reporting

A new FDA proposal is meant to streamline voluntary malfunction summary reporting for medical device companies. The proposal – which is now under a comment period until Feb. 26, 2018 – would allow a medtech company to provide certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis – instead of