My daughter Shanni and I just came back from Hsinchu, Taiwan where I was invited to deliver a keynote lecture at the 2014 International Symposium on VLSI Design, Automation and Test. The lecture was titled “Electroceuticals – Replacing Drugs by Devices Enabled through Advanced VLSI Technologies” Here is the abstract: Electroceuticals are medical devices that
St. Jude Medical today announced the approval of its Protégé™ IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation (SCS) technology upgrades as they are approved to be made via software updates. According to the press release: Chronic pain sufferers implanted with
Yesterday I visited the Udvar-Hazy Center of the Smithsonian Air & Space Museum in Chantilly, VA. There I found this demo rechargeable pacemaker being displayed as a spinoff of NASA’s technology with the following explanation: I can’t remember exactly where I found the picture of a Pacesetter model BD102 VVI, but the story behind it
I just came back from Beijing where we are in the process of registering our AIMD systems. The process if very different than submitting an application to a EU Notified Body or to FDA. This is because China’s State FDA (S-FDA) doesn’t accept testing performed abroad. S-FDA only accepts testing performed at one of the Chinese
On January 20, 2014, Mass Device reported that Greatbatch filed a CE Mark application for its spinal cord stimulation system with German notified body TÜV SÜD America. The spinal cord stimulation system comes from Greatbatch’s subsidiary, QiG Group. The company also applied for pre-market approval last month.
On Jan 29, 2014, Second Sight Medical announced that it had performed the first commercial implants of the Argus II visual prosthetic at the University of Michigan’s Kellogg Eye Center. Second Sight plans to provide updates during a press conference at the American Society of Cataract and Refractive Surgery conference in April, after the patients complete
St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy. The LEADLESS II pivotal trial is a prospective, non-randomized,
St Jude Medical announced that its Cardiac Rhythm Management sales increased 5 percent on a constant-currency basis over the fourth quarter of 2012. Neuromodulation sales for the same period increased by 2%. According to the press release: Cardiac Rhythm Management Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $705 million for
Boston Scientific announced that it has continued to improve performance in the company’s Cardiac Rhythm Management business, achieving revenue growth of 3 percent versus the prior year period on a constant currency basis from $457M to $468M.
Medtronic’s new Reveal LINQ Insertable Cardiac Monitor is a tiny implantable device that weighs less than three grams and is far less invasive than any previous loop recorder. The figure above shows its diminutive size compared to the Reveal XT device – it is a full 87% smaller! The Reveal LINQ is a leadless device that