Blog Tag: Medical Device

First Ever Marijuana-Related Medical Device Approved

First Ever Marijuana-Related Medical Device Approved

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

Boston Scientific Announces Acquisition of EMcision

Boston Scientific Announces Acquisition of EMcision

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

Johnson & Johnson Acquires French Surgical Tech Firm Orthotaxy

Johnson & Johnson Acquires French Surgical Tech Firm Orthotaxy

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

European Commission Proposes Stronger Cooperation for Health Technology Assessment

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 Develops Device to Combat Antibiotic Resistance

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.

First-Ever De Novo Clearance by FDA’s Orthopedic Branch

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

Popular Social Media Platforms in the Pharma Industry

Social Media Success: Trends in Pharma Digital Strategies

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

Digital Currencies and Blockchain in the Medical Arena

Recently, digital currencies, such as bitcoin, have greatly increased in popularity. Some of this popularity may be attributed to digital currencies’ many purported advantages over traditional currencies, such as that blockchain

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

EIT Acquires Patent Portfolio For 3D Printed Spinal Fusion Cages

On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio, a spinal surgeon

Pediatric Healthcare Innovators Compete for Funding

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

Teleflex Acquires UroLift® Maker NeoTract for $1.1 Billion

Teleflex Acquires UroLift® Maker NeoTract for $1.1 Billion

Wayne, Pennsylvania-based Teleflex Inc.  announced it will purchase privately-held NeoTract Inc. for approximately $1.1 billion. According to the press release, Teleflex will pay NeoTract $725 million when the deal closes and

Nanochip Device with Potential To Heal Tissue and Organs

According to a regenerative medicine article published online on August 07, 2017 in the journal Nature Nanotechnology titled “Topical tissue nano-transfection mediates non-viral stroma reprogramming and rescue”, Researchers

The Medical Device Tax Lives On

For opponents of the 2.3 percent medical device tax, it looked like the repeal/replacement of the Affordable Care Act would alleviate their concerns.  However, following the failure of repeal legislation that would have killed off,

K2M Obtains Exclusive License to Patent Portfolio

K2M Group Holdings, Inc. recently announced its acquisition of a portfolio of 17 issued and pending patents for expandable interbody technology.  According to K2M, the company is a global leader in the medical device industry and provides

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

Excelsius GPSTM: Globus Medical Receives 510(k) Clearance for Robotic Surgery Platform

Globus Medical announced early today that the Excelsius GPSTM surgical platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as reported by a press release dated August 17, 2017.

Globus Medical, which

House Passes Bill Relaxing Reporting Requirements

The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017.  This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA.  Previously, companies had to submit a report

FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k).  The Notice indicates that anyone with

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the Prescription Drug

Medtronic’s Recent Interactions with the FDA

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency.  Below is a brief summary of some recent of Medtronic’s