Blog Category: Blog

Netherlands Adopts US FDA-based UDI System for Medical Devices

A voluntary agreement (link in Dutch) was consummated by the Dutch Ministry of Health, industry, and hospitals. According to an Emergo blog post, under the terms of the agreement, the Netherlands will adopt the US Food and Drug Administration’s

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

Recall Highlights Medical Device Cybersecurity Issues

On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or rapid depletion

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

Takeda Pharmaceuticals Explores GI Devices in New Partnership with Nanotechnology Company

Takeda Pharmaceutical Company, a Japan-based global pharmaceutical company, recently announced an agreement with BioSurfaces Inc., a small Massachusetts research company, to research the development of medical devices for the treatment

Speedboat RS2 Endoscopic Device Receives FDA Clearance

UK-based Creo Medical recently announced the clearance of its Speedboat RS2 surgical endoscopic device for minimally invasive removal of lesions in the bowel.

According to the press release, the Speedboat RS2 device and the associated

Gilead to Acquire Kite Pharma for $11.9 Billion

Gilead to Acquire Kite Pharma for $11.9 Billion

Gilead Sciences, Inc. recently announced an agreement to acquire Kite Pharma, Inc. for $11.9 billion.  According to the announcement, Kite Pharma focuses on cell therapy treatment for cancer, which involves the genetic engineering

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

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

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

Embrace™ Neonatal MRI Device Gains FDA Clearance

On July 20, 2017, the Food and Drug Administration announced the clearance of “the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU)” to

Healthcare Industry May Not Be Prepared For Internet of Things

A recent survey conducted by ZingBox, a Silicon Valley internet security startup, found that more than 90% of healthcare IT networks have Internet of Things (IoT) devices. The survey further found that more than 70% of IT departments believe

Senior Partner Gerard von Hoffmann Joins Knobbe Martens San Diego Office

Knobbe Martens, one of the nation’s leading intellectual property and technology law firms, recently announced that senior partner Gerard von Hoffmann has relocated from Irvine to the firm’s San Diego office in Del Mar Heights.

Von

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

Philips Acquires Spectranetics for $2.16 Billion

Philips Acquires Spectranetics for $2.16 Billion

According to a June 28, 2017 press release, Dutch healthcare company Philips has agreed to buy Colorado Springs-based Spectranetics Corporation, a cardiac device manufacturer, for approximately 1.9 billion euros ($2.16 billion),

Researchers Announced A New Implantable Energy Storage System Powered By The Patient’s Body

Researchers Announced A New Implantable Energy Storage System Powered By The Patient’s Body

UCLA announced that scientists from UCLA and University of Connecticut designed a new form of energy storage for powering implantable medical devices that do not require a battery.  According to the announcement, this design makes it

Philips Buys RespirTech for Undisclosed Amount

Philips Buys RespirTech for Undisclosed Amount

Dutch conglomerate Philips recently announced that it will purchase Respiratory Technologies Inc. (RespirTech). According to its website, RespirTech describes itself as a St. Paul, Minnesota-based provider of inCourage vests, which