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AdvaMed Raises Questions With FDA’s Combo Product Proposed Rule

AdvaMed is taking issue with the US Food and Drug Administration’s product jurisdiction proposed rule, which the device group thinks strays from how the 21st Century Cures Act defined combination products, according to comments released Monday. Some of the proposed revisions run counter to the plain language and intent of Section 3038 of the Cures Act , AdvaMed said. The group is seeking to clarify that a combination product’s primary mode of action shall not be determined to be that of a drug or biologic solely because the product features “any chemical action” in or on the body. “Given the...

Study -
Stimulation of Brain’s Reward System Leads to Reduction in Cancer Tumors

Scientists at Technion – Israel Institute of Technology have come up with a surprising way of fighting tumors and in the process showed that our brains have a role in preventing the growth of cancers. The researchers, who reported their findings in journal Nature Communications , artificially stimulated the reward system of mice stricken with cancer. What the investigators showed is that over time, the mice that received stimulation had significantly smaller tumors than control mice that were not administered the therapy. The team believes that their stimulation affected the nervous system so...

UK -
Register as a manufacturer to sell medical devices

Register a manufacturer or authorised representative (agent) for a manufacturer, to sell medical devices, including in vitro diagnostic (IVD) medical devices. Overview If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised...

Discovery -
Device Detects Mosquitoes Carrying Pathogenic Viruses

Mosquitoes are usually only an unpleasant nuisance, but when they’re carrying diseases we only find out once people start showing up sick at hospitals and clinics. A spinoff from Purdue University is hoping to give public health professionals, and mosquito eradication programs, an early warning system to know where to direct their resources. The company, called SMK Diagnostics that’s headquartered in West Lafayette, Indiana, has developed a sensor that can identify the presence of infectious viruses within mosquitoes and to name specifically which flaviviruses they are...

CDRH Draft Plan for Abbreviated 510(k) Option Raises Questions

The Medical Imaging & Technology Alliance (MITA) and AdvaMed, among others, voiced concerns with how FDA’s Center for Devices Radiological Health (CDRH) intends to expand on the existing Abbreviated 510(k) program as described in a draft guidance from April. The draft left commenters puzzled since agency officials had indicated the expanded program would allow for greater flexibility when the plans were first announced last year. The industry groups commended CDRH for the attempt to identify new ways to reduce burden on industry. But the draft guidance ultimately under-delivered on the...

Medtronic’s HVAD Heart Pump FDA Approved for Less Invasive Implantation

Medtronic’s HVAD System, a left ventricular assist device, can now be implanted via a thoracotomy , a less invasive procedure than a median sternotomy . Moreover, a thoracotomy means that future procedures that may require access through the chest can still be performed in what are already risky patients. The HVAD System is indicated for those with advanced, refractory heart failure, both as a bridge to a heart transplant and as a final therapy if a transplant is not an option...

Research -
Researchers Achieve First 3D Printing of Human Corneas

Researchers in the UK have achieved the first 3D printing of human corneas that can potentially be used in replacement surgeries. In doing so, they have paved the way for an unlimited and easy-to-fabricate supply of new corneas to patients that need them, they said. Key to the achievement by scientists at Newcastle University is a novel bio-ink—a gel comprised of alginate, a polysaccharide derived from seaweed, and collagen, the main structural protein in cornea. The ink met three key criteria necessary for the fabrication of corneas, Che Connon, professor of tissue engineering at the...

Discovery -
Breathing Easier with Single-Use Bronchoscopes

A recent study, funded by 3M Company and supported by Healthmark Industries, found that most of the reusable bronchoscopes it examined, even when cleaned and disinfected using current reprocessing guidelines, remained contaminated or damaged. “The results are worrisome, as patients undergoing bronchoscopy are commonly at high risk for infection due to transplant status, critical illness, or immune-suppression due to malignancy or chronic disease,” states the study, “ Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes ." The 2017 study was...

China -
Changes to Chinese Medical Device Regulations would Benefit Foreign Manufacturers

Chinese regulators have drafted changes to Order No. 650 covering various medical device regulatory requirements. Proposed changes would affect product test reports, clinical evaluation report (CER) requirements, importing of innovative devices, and more. The Chinese government has not yet announced firm implementation timeframes for these changes...

Europe -
Le Règlement UE 2017/745 : vers un désastre industriel ?

Toutes les dénégations officielles n’empêchent pas de penser que l’affaire PIP a servi de détonateur, bien au-delà du vrai risque sanitaire qu’elle représentait, pour punir globalement tout un secteur industriel. C’est inédit. Une brebis galeuse, pourtant sévèrement sanctionnée judiciairement, a donc été la cause de l’élaboration d’un nouveau règlement UE, imposé au monde des dispositifs médicaux, au lieu d’un remodelage et d’un renforcement ciblé de l’architecture règlementaire actuelle, comme prévu initialement. Soyons clair, notre propos n’est surtout pas de dire que des produits de santé...



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