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Pediatric Healthcare Innovators Compete for Funding

The FDA, according to its website, currently supports eight consortia that provide advice and funding to help commercialize technologies for pediatric care. The FDA defines “pediatric” as encompassing devices used for...more

9/11/2017  /  FDA , Grants , Innovation , Pediatrics

ECRI Institute Releases Guidance on How to Protect Your Medical Device Systems

The ECRI Institute released new guidance in its article: “Ransomware Attacks: How to Protect Your Medical Device Systems” on May 18, 2017. The report recommends various protective actions for hospitals to take and points to...more

Voxello Receives FDA 510(k) Clearance for the Noddle Communication Device

Voxello recently announced FDA 510(k) clearance of its noddle™ device, following submission of its application in October 2016. According to the press release, the noddle gives patients who are unable to speak a way to...more

Increase in Funding to Med Device Startups

Despite a drop in the second quarter of 2016, medical device funding is expected to finish stronger this year than in 2015. CB Insights has released a report on the funding and deal activity within the medical device...more

Wright Medical To Sell Tornier Business to Corin for $33 Million

According to press releases, Wright Medical Group N.V. plans to sell its Tornier hip and knee business to Corin Orthopaedics Holdings Ltd. for about $33 million in cash. This deal comes shortly after Wright and Tornier...more

The Brexit Effect on Medical Devices

The medical device industry has been struck by a wave of uncertainty in the wake of the United Kingdom’s (UK) historic vote to leave the European Union (EU). Until the breakup becomes official, British legislation should...more

CardiAQ Wins $70 Million in Trade Secrets Suit

A federal jury found in favor of CardiAQ in a lawsuit filed against former service provider, Neovasc. The jury found that Neovasc breached the non-disclosure agreement between the parties, misappropriated CardiAQ’s trade...more

FDA Proposes Public Notification of “Emerging Signals”

The Food and Drug Administration has proposed a new policy for earlier public notification of medical device safety issues. These notifications will be in addition to the recall notices, safety communications, and press...more

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