Genetic analysis instrument maker Illumina Inc. said Friday that a federal jury ruled against it in a patent infringement trial, and ordered the San Diego company to pay $96 million in damages to Syntrix Biosystems. The jury found that Illumina's BeadChip products infringed on a patent belonging to Syntrix.
Orthopedic maker Stryker Corp. said Tuesday that it received a warning from government regulators about quality control issues and unapproved marketing of medical devices. The company said it got the letter from the Food and Drug Administration following a November inspection of its Portage, Mich., facility.
By injecting the aforementioned inebriated mice with nanocapsules full of enzymes that are instrumental in alcohol metabolism, researchers have not only sobered the little vermin, but created a unique drug delivery technology that could disrupt the medical industry.
Early results from a key study of Boston Scientific Corp.'s Watchman device suggested it is safer than previous testing found, but may not be better than a drug that is used now for preventing strokes, heart-related deaths and blood clots in people with atrial fibrillation over the long term.
Jurors on Friday awarded the damages in 65-year-old Loren Kransky's negligence and defective design suit against the giant health care company and its DePuy Orthopaedics subsidiary. It's the first of thousands of similar cases that attorneys say left people with crippling problems or in need of other replacement surgeries.
It's the first verdict in about 4,000 lawsuits filed against the giant health products maker based in New Brunswick, N.J. At least one plaintiff has won a lawsuit against one of the other 30-plus makers of the once-popular implants, used to lift sagging pelvic organs back into place.
Health care giant Johnson & Johnson says it's under investigation by federal prosecutors over the company's practices in marketing a line of hip replacements recalled two years ago because many failed and had to be replaced within five years.
Printing out body parts? Cornell University researchers showed it's possible by creating a replacement ear using a 3-D printer and injections of living cells. The work reported Wednesday is a first step toward one day growing customized new ears for children born with malformed ones, or people who lose one to accident or disease.
Heart device maker Abiomed Inc. said Wednesday that U.S. regulators have wrapped up a 20-a-month investigation into improper marketing of one its products, notifying the company that the case has been closed after evaluating the company's corrective actions.
If you have ever had a flu shot, then there is a good chance that in a small way you are connected to our next guest. We welcomed to the show Butch Rich, Director of Operations with Rame-Hart. Rame-Hart began as a design and build machine shop and today has evolved into a leading manufacturer of Egg Harvesters and Inoculators
The Food and Drug Administration on Thursday approved the Argus II Retinal Prosthesis System as the first treatment for an inherited disorder that causes the breakdown of cells in the retina, a membrane inside the eye. The technology will initially only be available to a small number of patients, but could eventually be used to treat vision disorders that affect millions of people.
A German newspaper reports that Johnson & Johnson is recalling thousands of hip implants 2 1/2 years after a similar recall. Handelsblatt reports that the Adept implants made by J&J's subsidiary DePuy Orthopaedics showed a failure rate of 12 percent after seven years. It said some 7,500 of the implants were shipped worldwide between 2004 and 2011.
Shortages have spurred innovations in autotransfusion, the process wherein a person receives his/her own blood for transfusion instead of banked donor blood. Typically, the blood can be harvested from the individual before a surgical procedure, but a new device makes it easier to collect blood lost during surgery and return it to the patient.
The company's Amplatzer TorqVue delivery system is used to mend a type of heart defect that causes holes in the upper chambers of the heart. St. Jude recalled all batches and models of the device Jan. 13 after a small number of incidents where the delivery system's wire fractured during surgery.
The user interface needs to be as simple as possible, yet provide the physician with accurate feedback. The device must be robust and able to be used for extended periods of time. As shown in Figure 1, the patient is required to wear a mask throughout the night.
While many women benefit greatly from the mesh surgery, the Food and Drug Administration has warned some can suffer complications, and many women have sued, claiming manufacturers should have warned of potential harm. But some doctors have said the FDA's warning — and the lawsuits against the manufacturers — are misguided.
The Watson supercomputer is graduating from its medical residency and is being offered commercially to doctors and health insurance companies, IBM said Friday. IBM Corp., the health insurer WellPoint Inc. and Memorial Sloan-Kettering Cancer Center announced two Watson-based applications — one to help assess treatments for lung cancer and one to help manage health insurance decisions and claims.
The Durham, N.C., company said Friday it has not decided on any specific alternative, and it has no time frame for completing its review. Tranzyme has no drugs on the market. It said in December it would end a mid-stage study of a treatment for diabetic gastroparesis because it failed to do better than a placebo.
The OM-CP-PR140, from Omega Engineering, is a pressure data logger designed for use in autoclave validation and mapping. This rugged device can withstand temperatures up to 140°C (284°F) and is completely submersible (IP68). The OM-CP-PR140 is built with a precision stainless steel pressure gauge.
Boston Scientific plans to cut as many as 1,000 additional jobs this year as the medical device maker expands a push to reduce operating expenses. The company's shares jumped in morning trading Tuesday, as it also reported a fourth-quarter profit and earnings outlook that topped Wall Street expectations.
Medical device manufacturing is subject to a complex network of regulations from a handful of different governing bodies such as the FDA and OSHA. If you’re planning to market and sell a new product, you have to coordinate with the equivalent bodies in every country.
Medical device maker Stryker is buying orthopaedic products maker Trauson Holdings Co. for $764 million in order to expand its business in China. Trauson's biggest shareholder, Luna Group, has agreed to tender 61.7 percent of the Trauson shares toward the offer, Stryker said. The acquisition is expected to close by the end of the second quarter.
The warning was expected after St. Jude announced in October that the plant had been visited by FDA inspectors. The staffers found inconsistencies in how the company manufactured and documented defibrillators, which are devices implanted in the chest to correct dangerous heart rhythms.
From IQ/OQ/PC (installation qualification/ operational qualification/performance qualification) documentation, to adherence to ISO 13485 quality management standards, to compliance with FDA good manufacturing practices; quality procedures and documentation pervade the entire organization.
Saint-Gobain Performance Plastics has completed the acquisition of American Fluoroseal Corporation (AFC), a Maryland based manufacturer of fluoropolymer bags for medical use and sterile sampling systems for pharmaceutical manufacturing processes. The company operates from a single location in Gaithersburg (Maryland, United States) where both engineering and manufacturing are located.