Blog Category: Blog

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

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

Cyberattacks and the Value of Medical Data

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

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

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

Veterans Association and IBM Watson Extends Oncology Partnership

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.

According to the press release, the partnership

Envision Healthcare to be Acquired by KKR for $9.9B

Envision Healthcare to be Acquired by KKR for $9.9B

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

Stryker to Acquire Surgical Smoke Evacuator Company SafeAir

Stryker to Acquire Surgical Smoke Evacuator Company SafeAir

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.

According to its website, SafeAir specializes in smoke evacuating diathermy

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

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

FDA Unveils Update to Software Precertification Program

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

First Prosthetic Iris Approved

First Prosthetic Iris Approved

On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research Consultants, Inc.,

First Thrombectomy Device Cleared for Pulmonary Embolisms

The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”).  According to Inari, the FlowTriever system is the first thrombectomy device cleared for

Apple Releases Electronic Health Record Aggregation Tool in iOS 11.3

According to an Apple press release, iPhone users will now be able to store and view their medical records on their phones as part of a new feature found in iOS 11.3.  Although many patients are already familiar with clinic-specific patient

Materialise Receives First-Ever 510(k) Clearance for Anatomical Model 3D Printing Software

Materialise Receives First-Ever 510(k) Clearance for Anatomical Model 3D Printing Software

3D printing specialist Materialise recently received FDA 510(k) clearance for its Mimics inPrint software. Mimics inPrint is said to use to create 3D anatomical models from medical image data and output those models to a 3D printer at the

China FDA Issues Guidance on 3D Printed Medical Devices

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

KnobbeMedical Named as a “Top 30 Medical Device Blog”

KnobbeMedical.com was recently named as a “Top 30 Medical Device Blog” by Feedspot. KnobbeMedical made the list along with other respected medtech industry blogs including MassDevice and MDDI Online based on several stated

FDA Approval for Auris’ Robotic Endoscopy Platform

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics,

Theranos Charges Provide Perspective for Medical Device Companies, Biotechnology Companies, and Investors

On March 14, 2018, the Securities and Exchange Commission (SEC) announced it filed charges against the founder and CEO of Theranos Inc., Elizabeth Holmes, and its former president, Ramesh Balwani.

Theranos describes itself as a privately

FDA grants De Novo Market Clearance of Artificial Intelligence Software

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform 

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

23andMe Wins FDA Approval for Test to Detect BRCA Mutations

The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants).  According to an FDA news release, the approved test is the

Cyborg-Enhanced Physical Therapy Approved

Cyberdyne, Inc. recently announced FDA marketing approval for its Medical HAL [Hybrid Assistive Limb] therapeutic device and services.  Cyberdyne describes itself as a Japanese company founded by Professor Yoshiyuki Sankai of the University