Drugs
The Bass Berry & Sims 2015 Healthcare Fraud and Abuse Review says that only a fraction of the $3.6 billion in Fiscal Year 2015 civil fraud recoveries involved matters concerning the drug industry, while a significant amount of them involved whistleblower actions raising issues of medical necessity and improper
Devices
The Association for Molecular Pathology (AMP) says it is “concerned and disappointed” over FDA enforcement action against doctors at two Texas hospitals for their laboratory-developed test for the Zika virus. “Given the ongoing outbreak of the infection in the Houston area, these types of tests are critical for patient
Devices
Department of Justice (DoJ) prosecutors are behaving like Mafia enforcers in their tactics with medical device companies they accuse of “corporate wrongdoing,” according to Minneapolis-based Vascular Solutions CEO Howard Root, who last month was acquitted by a jury of all DoJ felony charges brought against him in an off-
Devices
FDA has cleared an InfoBionic 510(k) for MoMe Kardia, a wireless, remote monitoring system designed to aid physicians in diagnosing cardiac arrhythmias in patients with a demonstrated need for such monitoring. The three-in-one device transitions between Holter, Event and Mobile Cardiac Telemetry modes remotely, which is intended
Devices
FDA’s Circulatory System Devices Panel has voted 9-0 to recommend approval of an Abbott PMA for the first fully absorbable drug eluting stent. Agency reviewers had determined that clinical data submitted showed that the device was not inferior to a traditional stent, according to a briefing document released
Devices
A 10/26-11/10/15 FDA inspection at Sure Tek Medical, Greenville, SC, found Quality System Regulation violations in the firm’s manufacturing of medical devices such as orthopedic and laparoscopic instruments. A 3/3 Warning Letter from the agency’s Atlanta District Office says that procedures for monitoring
Devices
CDRH conducted 5% fewer device quality systems (QS) surveillance inspections last year, according to just-posted inspection metrics. The Center conducted 2,104 QS inspections, which is 109 less than in 2014. More foreign inspections were performed in 2015 (620 inspections) than in 2014 (594), which translates to a 4%
Devices
A CDRH safety alert says Olympus has updated reprocessing instructions for its 160F/VF duodenoscope models to include a more rigorous protocol for pre-cleaning, manual cleaning and high-level disinfection procedures, specifically additional flushing, brushing and increased flushing volume. It also recommends a reusable brush (Model MAJ-1534) to
Devices
At a 2/18 FDA/Industry MDUFA 4 reauthorization meeting, AdvaMed, MDMA (the Medical Device Manufacturers Association, and MITA (the Medical Imaging and Technology Alliance) presented an updated proposal package including continuation of MDUFA 3 base resources to maintain the MDUFA 3 FTE levels and maintain FDA’s current performance,
Devices
Abbott Vascular has begun a Class 1 recall of its Vascular MitraClip Delivery System, which is intended to treat patients with degenerative mitral regurgitation. The company has received reports of cases where the clip delivery system could not be detached from the clip due to a device malfunction. An agency
Devices
An 8/4-8/13/15 and 10/6-11/4/15 FDA inspection at Innovative Sterilization Technologies, Dayton, OH, found Quality System Regulation violations in the firm’s work as the specification developer of the One Tray sealed sterilization container. A 3/2 Warning Letter from the agency’s
Devices
An Abbott PMA for the first fully absorbable drug eluting stent contains clinical data showing the device was not inferior to a traditional stent, according to an FDA briefing document released in advance of a 3/15 Circulatory System Devices Panel meeting. While clinical data for Abbott’s Absorb GT1
Devices
A new Harvard analysis lends support to recent bills introduced in the House and Senate that propose shorter “pre-market” clinical testing and better “post-market” surveillance than current standards for certain devices. The analysis is limited to coronary stents, and the researchers note their theoretical model “provides guidance on
Devices
CDRH is escalating its enforcement against laboratory-developed tests being marketed for Zika virus detection. Last week, the Center sent a letter to MD Biosciences challenging its marketing of the Zika Virus RNA by RTPCR Assay (see story). Now, the agency has sent two additional letters — one to First Diagnostic
Devices
Teleflex has begun a recall of its Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits because the sheath body may become separated from the sheath hub. If the separation occurs, the patient may bleed from the sheath. Interruption or loss of intra-aortic balloon pump treatment may
Drugs
A coalition made of 15 public health and patient advocate groups have written Senate lawmakers opposing seven bills that were reported out of the Senate HELP Committee 3/9 (see earlier story). The groups say they are “concerned that the focus of these bills is on getting medical products to
Drugs
It’s still too soon to tell whether the Justice Department’s focus on individual accountability for corporate wrongdoing will have a real and lasting impact, according to a Washington Legal Foundation Legal Backgrounder by two Bryan Cave attorneys. Although the policy announced last fall by deputy attorney general Sally
Devices
A California federal court decision involving complications allegedly caused by placement of Bayer’s controversial Essure permanent contraception device is interesting for its treatment of preemption and, even more so, for its treatment of causation, according to attorney Steven Boranian (Reed Smith), writing in an online blog post. The device
Devices
FDA has cleared a Cochlear Ltd. 510(k) for the Cochlear Baha 5 SuperPower Sound Processor for use in children and adults with high degrees of mixed hearing loss. The device is designed to make difficult listening situations easier, according to the company, which describes it as the “first and
Devices
FDA says a MD Biosciences laboratory-developed test for detecting Zika virus requires 510(k) clearance or PMA approval. In a just-posted letter to the company, the agency says the Zika Virus RNA by RTPCR Assay, which is intended “to provide a reliable, accurate and rapid method of testing
Devices
FDA has cleared a Visunex Medical Systems 510(k) for its Visunex Medical Systems PanoCam Pro Wide-field Imaging System for imaging newborn infants for vision disorders. The wireless device can help detect external, anterior, and posterior segment vision disorders that may have long-term effects, according to the company.
Drugs
A Senate bill to move FDA funding from a discretionary to mandatory status would be a mistake, according to researchers from the Mercatus Center at George Mason University. The researchers oppose a Democrat-sponsored bill called the National Biomedical Research Act that would increase funding for targeted biomedical initiatives through