Knobbe/Martens: Intellectual Property Law

Medical Devices & Procedures

Subscribe to Medical Devices & Procedures Blog

FDA Grants Breakthrough Status to Dthera Sciences' Alzheimer's Therapeutic

September 4, 2018 Robert J. Hilton, Ph.D.

On August 23, 2018, Dthera Sciences announced that the Food and Drug Administration granted Breakthrough Therapy designation to its Alzheimer’s disease therapeutic device. According to the FDA, Breakthrough Therapy designation is intended to help patients have more timely access to breakthrough technologies that provide treatment for diseases for which no approved treatment exists or which offer significant advantages over existing treatments. A therapy that receives Breakthrough Therapy designation will be reviewed within 60 days of receipt.

Boston Scientific Buys Venous-Stent Maker VENITI

August 29, 2018 Michael P. Burns, Ph.D.

Boston Scientific recently announced an agreement to acquire privately-held VENITI, Inc. for $160 million. According to the press release, VENITI submitted a pre-market approval application with the U.S. Food and Drug Administration in June 2018 for the VICI stent system for treating obstructive venous disease. The VICI stent system received CE Mark approval in 2013.

BioSig Technologies Receives FDA 510(k) Clearance for Its Noninvasive Electrophysiology Information System

August 16, 2018 Sabrina Wang

The Los Angeles-based medical device company BioSig Technologies, Inc. announced in a press release the FDA 510(k) clearance of its PURE EP System, which is designed to aid electrophysiology procedures, such as cardiac ablation for treating atrial fibrillation.

MaxQ-AI Files for IPO

August 15, 2018 Brandon G. Smith

MaxQ-AI (previously known as MedyMatch) recently filed for an $8 million IPO.  According to Nasdaq, MaxQ-AI filed confidentially on February 13. The prosepectus filed with the SEC describes MaxQ-AI as “a clinical stage artificial intelligence, or AI, company specializing in improving diagnostic accuracy through deep learning technology.”  MaxQ-AI is currently classified as an “emerging growth company” under the 2012 JOBS Act (meaning it had revenues of less than $1.07 billion last fiscal year).  MaxQ-AI’s CEO is Gene Saragnese.

Cyberattacks and the Value of Medical Data

August 1, 2018 Shuchen Gong

On July 20, 2018, SingHealth, a Singapore healthcare institution consisting of four public hospitals, five national specialty centers and a network of nine polyclinics, reported that it had been the target of a cyberattack resulting in the information of around 1.5 million individuals being compromised.

FDA Announces Innovation Challenge for Devices to Prevent and Treat Opioid Use Disorder

July 25, 2018 Jordan E. Gottdank

The Food and Drug Administration (FDA) has announced a medical device innovation challenge to help address opioid abuse and misuse.  With the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder, the FDA intends to encourage development of medical devices that will help to combat the ongoing opioid crisis.

Veterans Association and IBM Watson Extends Oncology Partnership

July 24, 2018 Raj D. Pai, PhD.

On July 19th, 2018, the United States Department of Veterans Affairs (VA) and IBM Watson Health announced an extension of their ongoing partnership to interpret cancer data in patients.

Envision Healthcare to be Acquired by KKR for $9.9B

July 17, 2018 Nathan J. Lee

Envision Healthcare Corporation (“Envision”) recently announced an agreement to be acquired by KKR & Co. L.P. (“KKR”) for about $5.5 billion in cash. The transaction is valued at $9.9 billion, including the assumption or repayment of debt.  The transaction remains subject to regulatory and shareholder approvals, but is expected to close in the fourth quarter of 2018.

Stryker to Acquire Surgical Smoke Evacuator Company SafeAir

July 17, 2018 Douglas B. Wentzel

Stryker recently announced an agreement to acquire SafeAir AG, a Swiss surgical smoke evacuation company.  The acquisition will likely close by the end of 2018.

Trump’s Chinese Tariffs Could Cost Medical Device Makers $138 Million Per Year, MITA Says

July 17, 2018 Neil G. Anderson

President Donald Trump’s 25 percent tariffs on Chinese imports went into effect on July 6, a move that, according to industry experts, could have wide-ranging effects on American medical device manufacturers.  In early April, RBC Capital Markets estimated the proposed tariffs could cost the entire medical device industry up to $1.5 billion each year.

Pages

Attorney Finder