Regulatory and Clinical Services for the Medical Technology Industry offered by M Squared Associates

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By introducing SCS to the CEB, the visual analog scale baseline was rapidly reduced. Our smart cup’s utility was demonstrated by amplifying and quantifying herpes simplex virus type 2 (HSV-2) with LAMP assay in our custom-made microfluidic diagnostic chip. Kiser and his colleagues worked painstakingly for five years, engineering the three materials that make up the ring and optimizing the device to reliably deliver fixed and efficacious doses of two medicines over a long period of time. Approval via 510(k) path requires “substantive equivalence” with a “predicate device” (see:The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]). Using properly folded and glycosylated proteins from our mammalian expression system gives our development team the edge in Lateral Flow Device development. The inventor, Patrick Kiser, a biomedical engineer from Northwestern University, feels women will use the device mostly for contraception, but would also benefit from being protected against HIV and herpes. Prior to this these fractures were pinned, plated, and casted, yet they would never knit together and heal.

Among the Israeli medical innovations that Israeli volunteers brought to Nepal last May to treat earthquake victims was the Pocket BVM (bag valve mask), a uniquely collapsible version of an essential resuscitation and respiratory support device. Data also show that MC provides significant protection against both HPV and HSV-2, reducing the risk of infection by about one-third for both viruses (13,17-19), in addition to reducing the risk of cervical cancer in female sex partners of circumcised men (20-22). The Safe Medical Device Act of 1990’s (SMDA’s) new section 515(i) requires FDA to order industry submission of a summary of and a citation to any information known or otherwise available to the manufacturer, including adverse safety and effectiveness information, for preamendments class III devices not yet subject to a 515(b) final order and to reconsider their classification in light of redefinition of class II. So, less than one woman in every 100 using an IUD will become pregnant in a year. performed immunostaining and quantification, electrophysiology experiments, generated figures. These companies are researching new point-of-care tests based on microfluidics. Claire decided to introduce herself.


Sharps injuries can occur at any time during the use or disposal of a device. Automatic maintenance of temperature. The compact PMU device is compatible with seven different hygiene modules which are individually packed, sterilized and provided with batch numbers. CONCLUSIONS: A low-cost mobile device can perform a blood-based HIV serodiagnostic test with laboratory-level accuracy and real-time synchronization of patient health record data. Improvement in skin laxity and fine wrinkles was seen after the second treatment in 19 of the 20 patients and after the third treatment in 100% of the patients. I can come to that conclusion because the addition of the sTMS is the only addition to my treatment. Candida’s home base is almost always in the intestines.

Consequently, at no point between Theranos opening its first wellness center in 2013 and a surprise inspection by the FDA in August did any federal official examine the company’s proprietary technology — either its Edison machine, which reads samples, or its “Nanotainer” device, which stores blood from pinprick testing. Or both. As a vaginal gel, tenofovir has also been shown to be effective at deterring herpes simplex virus. Generally, women who have genital herpes prior to becoming pregnant have a low risk of passing it to their babies. The light is projected through each well and collected by 96 plastic optical fibers. The molecular diagnostics market is expected to grow as more assays become FDA approved and testing shifts to molecular methods from microbiology or immunoassay disciplines. Adverse event rates were similar to those observed with conventional surgical circumcision and were managed with, at most, minor interventions, resolving with no long-term sequale.

Devices and treatments litter the market just waiting to be trialled and tested. Many lawsuits followed and A.H. The second FDA letter had to do with how it was testing the samples. 16. D(10) values were calculated and used to extrapolate the extent of inactivation after 2 hours. Today, keratoprosthesis has a role in combating corneal blindness in carefully select patients with complex ocular disease who are at high risk for donor graft failure, despite the potential risk of significant postoperative complications. The failure rate of IUDs almost similar to that of tubal sterilization.

See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. There are lots of products in the market that are running parallel offering equal features and benefits. Whether molecular cues detected by axons can be relayed to cell bodies and harnessed to regulate latent genome expression in neuronal nuclei is unknown. The Raindrop Near Vision Inlay is the second FDA-approved implantable corneal device for correction of near vision in patients who haven’t had cataract surgery and the first implantable device that changes the shape of the cornea to achieve improved vision.