Blog Tag: Medical Device
The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.
The FDA describes
On November 9, 2018, Cook Medical LLC filed a petition with the Patent Trial and Appeal Board requesting inter partes review (IPR) of U.S. Patent No. 6,306,141, assigned to Medtronic Vascular, Inc. The ‘141 Patent is entitled “Medical
The U.S. Food and Drug Administration (FDA) announced an agreement with the U.S. Department of Homeland Security (DHS) to strengthen the partnership between the agencies and “stay a step ahead of constantly evolving medical device cybersecurity
In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the premarket
The medical device and related markets have shown some growth recently. For example, IHI, an iShares U.S. Medical Devices ETF, has a total return of about 24% year-to-date in 2018. In the same time period, the S&P 500 has a return
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
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
J&J Accepts Platinum Equity’s $2.1B Offer for its LifeScan Subsidiary; Receives Offer for Advanced Sterilization Products Subsidiary
On June 12, 2018, Johnson & Johnson announced acceptance of an offer from Platinum Equity, a private investment firm, to acquire its diabetic monitoring unit, LifeScan, for approximately $2.1 billion. In response to the acquisition,
The U.S. Food and Drug Administration (FDA) recently updated its software Precertification Program. A working program was originally rolled out in April 2018, but the program was updated in response to requested public input. The FDA
The market for medical device connectivity is projected to reach about $2.6 billion by the year 2023, according to a report published in April 2018 by several publishers. The report states that the connectivity market for 2018 is expected
DePuy Synthes, a part of the Johnson & Johnson Medical Devices Companies, announced recently that it has signed a definitive agreement to acquire the assets of Medical Enterprises Distribution, LLC, which includes the automated ME1000™
More than two and a half years after the China Food and Drug Administration (CFDA) formally approved its first three-dimensional (3D) printed medical device for mass production, a hip implant co-developed by Peking University’s
According to PR Newswire, the Israeli Ministry of Health has granted initial approval to Tel-Aviv-based Kanabo Research for their VapePod vaporizer product as a medical device. PR Newswire notes that with this approval, Israel has become
On March 5, 2018, Boston Scientific announced its acquisition of EMcision, a privately held company in the United Kingdom and Canada. According to Boston Scientific, this acquisition will expand its range of medical devices in the field
On February 20, 2018, Johnson & Johnson Medical Devices Companies announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery
On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when conducting a Health Technology Assessment (HTA) of new medicines and certain new medical
Boston Scientific Announces Agreement for Investment & Acquisition Option with Transcatheter Annuloplasty Ring Developer Millipede, Inc.
Global medical device company Boston Scientific has announced on January 24, 2018, an agreement to make a $90 million investment in privately-held medical device company Millipede, Inc. Millipede has developed a non-invasive
Da Volterra, a biotech company developing products in the antibacterial field, has announced results in a human clinical trial for DAV132, a product said to prevent life-treating bacterial infections during antibiotic treatments.
According to IlluminOss Medical, Inc.’s recent press release, the company has successfully obtained the first-ever de novo clearance from the FDA’s Orthopedic Branch for its minimally invasive bone stabilizaion system
According to data published by business intelligence firm Cutting Edge Information, the majority (73%) of pharmaceutical marketing teams expect to use or continue to use the popular social media forum Facebook to facilitate their digital