Ingeni uso e-BrainIngenious e-BrainNurturing Innovations - Fostering Business

BR HealthcareJan 2016

Thornhill Research Inc. Recalls MOVES Ventilator

System

Thornhill Research Inc. is recalling the MOVES

ventilator system because excess glue on the

battery connectors

Dräger recalling the PS500 battery power

supply

Dräger Evita V500 and Babylog VN500 Ventilators is recalling PS500 Battery

Power Supply due to unexpected shut down of ventilators and which may

cause patient injury or death.

FDA issued final guidance to address novel

sterilization processes

More than seven years after publishing draft guidance on the topic, finally the US Food

and Drug Administration (FDA) announced the final

guidance on “Submission and Review of Sterility

Information in Premarket Notification (510(k))

Submissions for Devices Labeled as Sterile.”

Lucy's Weight Loss System Issues Voluntary Nationwide

Recall of Pink Bikini and Shorts on The Beach Dietary

Supplements Due To Possible Undeclared Active

Pharmaceutical Ingredient

Lucy's Weight Loss System of Arlington, TX, is voluntarily recalling all

lots of Pink Bikini and Shorts on the Beach Capsules in all colors, 30

count (750MG per capsule) to the consumer level. Pink Bikini and

Shorts on the Beach may contain an undeclared ac�ve pharmaceu�cal

ingredient. The affected lot belongs to lot number C964601 with an

expira�on date of 04/30/2016.Lucy's Weight Loss System has not

received any complaints to date.

For more details click here

Thermo Fisher to acquire Affymetrix for $1.3 billion

Thermo Fisher Scien�fic Inc.(NYSE: TMO), the world leader in serving science, and Affymetrix Inc.(NASDAQ: AFFX), a leading provider of cellular and gene�c analysis products, announced that their boards of directors have unanimously approved Thermo Fisher's acquisi�on of Affymetrix for$14.00 per share in cash. The transac�on represents a purchase price of approximately $1.3 billion.

For more details click here

Charles River Labs to buy WIL Research for $585 million in cash

Charles River Laboratories Interna�onal, Inc. (NYSE: CRL) announced that it has entered into a defini�ve agreement to acquire WIL Research for approximately $585 million in cash, subject to customary closing adjustments.

For more details click here

Tensha Therapeu�cs to be acquired by Roche for upfront$115 million cash

Tensha Therapeu�cs, a privately-held company based in Cambridge, MA, announced today it will be acquired by Roche. Under the terms of the agreement, Tensha's shareholders will receive an upfront cash payment of $115 million, plus addi�onal con�ngent payments of up to $420 million based on the achievement of certain predetermined clinical and regulatory milestones.

For more details click here

Key Merger & Acquisitions

Drug Recalls

Baxter ini�ates Voluntary Na�onwide Recall of Select Lotsof IV Solu�ons Due to the Poten�al for Leaking Containersand Par�culate Ma�er

Baxter Interna�onal Inc. announced today it is voluntarily recalling four lots of intravenous (IV) solu�ons to the hospital/user level due to the poten�al for leaking containers and par�culate ma�er. Baxter was made aware of these issues as the result of two complaints for leaking containers and one customer complaint each for three lots due to par�culate ma�er.

In each case, the issue was discovered prior to pa�ent administra�on and there have been no adverse events associated with these incidentsreported to Baxter to date.

For more details click here

Master Herbs, Inc. Issues Voluntary Na�onwide Recall of All Lots of Licorice Coughing Liquid Due to the Presence of Morphine

Pomona, CA, Master Herbs, Inc. is voluntarily recalling ALL LOTS of Licorice Coughing Liquid, cough syrup in 100 ml bo�les to the consumer level. This product has been found to contain morphine, which is an opioid, and it is not declared on the label. Opioid is an ingredient of Compound Camphor. Compound Camphor is declared on the label of the product, but not its ingredients.

For more details click here

Baxter ini�ates voluntary recall of two lots of iv solu�ons due to the poten�al presence of par�culate ma�er

Baxter International Inc. announced today it is voluntarily recalling two lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter.

The affected lot belongs to lot numbers 2B1301 and 2B0043 and distributed to customers and distributors in the United States between October 7, 2014 and July 14, 2015.

For more detail click here

Abbo�'s Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance

Abbo�'s Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medica�ons, sterile solu�ons, eyedrops, and eye ointments. All recalled products were distributed to pa�ents, physician offices and clinics, and veterinarians withinCalifornia.

For more details click here

R Thomas Marke�ng LLC In Conjunc�on With Just EnhanceLLC Issues Na�onwide Recall Of Black Ant, Herb Viagra, Real Skill, Weekend Prince, African Black Ant And Stree Overlord Along With Mul�ple Other Products Due To Undeclared Sildenafil

R Thomas Marke�ng LLC is voluntarily recalling all lots of the following products to the consumer level:· Black Ant: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules total)· Herb Viagra: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)· Real Skill: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)· Street Overlord: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules)· Weekend Prince: BIG BOX (24 individual cards / 2 capsules per card / 48 capsules)· African Black Ant: BIG BOX (8 small boxes / 6 capsules per box / 48 capsules)

For more details click here

Dräger Evita V500 and Babylog VN500 Ven�lators - Issue with Op�onal PS500 Ba�ery Power Supply May Cause Ven�lators to Shut Down Unexpectedly

Dräger is recalling the PS500 ba�ery power supply because a so�ware issuecauses shorter than expected ba�ery run �mes. The so�ware issue with the power supply also prevents the appropriate alarm from sounding 5 minutes before the ba�ery runs out of power and the device shuts down. If the ven�lator shuts down, a pa�ent may not receive necessary oxygen. This could cause pa�ent injury or death.

For more details click here

Brainlab Cranial Image-Guided Surgery (IGS) System – Naviga�on Inaccuracy

Brainlab Cranial IGS System shows the area of interest and the posi�on of an instrument rela�ve to the pa�ent's anatomy to enable minimally invasive surgical procedures.

Brainlab is recalling the Cranial IGS System due to poten�al inaccuracies in the display by the naviga�on system compared to the pa�ent anatomy. This could lead to inaccurate, ineffec�ve medical procedures, and serious life-threatening injuries including death.

For more details click here

St. Jude Medical Recalls Op�sure Dual Coil Defibrilla�on Leads Due to Damage that May PreventPa�ent Therapy

Recalled Devices are Op�sure Dual Coil Defibrilla�on Leads. The Op�sure Dual Coil Defibrilla�on Leads are implanted wires that connect a defibrillator to a pa�ent's heart. The defibrillator system senses the pa�ent's heart rhythm and delivers electrical pulses or shocks when it detects a faster than normal heart rate (tachycardia) or completely disorganized electrical ac�vity (fibrilla�on).

St. Jude is recalling the Op�sure leads due to a manufacturing error that may have caused damage to the insula�on layer of one of the shock coils. Depending on device programming and the depth of the cut, this could result in the inability of the defibrillator to deliver electrical therapy to the pa�ent. The use of affected products may cause serious adverse health consequences, including pa�ent injury or death.

For more details click here

Stryker Fuhrman Pleural and Pneumopericardial Drainage Sets - Catheter May Break During Inser�on

Recalled Device are Fuhrman Pleural & Pneumopericardial Drainage Set. The Fuhrman Pleural/ Pneumopericardial Drainage Set is used to remove air from the sac (pericardium) surrounding the heart, or to drain air or fluid from thin covering (pleural cavity) that protects the lungs. The primary users of this device are medical doctors.

For more details click here

Medical Devices Recall

Thornhill Research Inc. Recalls MOVES Ven�lator System Due to Ba�ery Problem

Recalled Devices are Thornhill Research Inc. MOVES Ven�lator System. The MOVES Ven�lator System is a portable emergency transport ven�lator that provides breathing support for adults pa�ents. The primary users of this device are medical doctors.

Thornhill Research Inc. is recalling the MOVES ven�lator system because excess glue on the ba�ery connectors may prevent theba�ery from powering the device a�er the ba�ery is stored.

Arkray Recalls SPOTCHEM II Test Strips Due to Inaccurate Blood Sugar Readings

Recalled Device: SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip

The Arkray Factory Inc. SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are used to test blood sugar (glucose) levels in blood samples. This product is intended for usewith the SPOTCHEM EZ analyzer.

For more details click here

Industry Guidance - US FDA

Submission and Review of Sterility Informa�on in Premarket No�fica�on (510(k)) Submissions for Devices Labeled as Sterile

This guidance document updates and clarifies the informa�on regardingsteriliza�on processes that we recommend sponsors include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity informa�on that we recommend sponsors include in a 510(k) submission.

For more details click here

Revised Preven�ve Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products

This guidance is the latest in a series of guidances addressing the risk of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) 1 transmission by blood and blood products.

For more details click here

Submission and Review of Steri�lity Informa�on in Premarket No�fica�on (510(k)) submission for Devices Labeled as sterile

This guidance documents updates and clarifies the informa�on regarding steriliza�on processes that we recommend sponsor include in 510(k)s for devices labeled as sterile. This guidance document also provides details about the pyrogenicity

This issue may prevent the ven�lator from providing pa�ent breathing support and could cause pa�ent injury or death.

For more details click here

informa�on that we recommend sponsor include in a 510(k) submission.

For more detail click here

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Ingenious e-Brain Solu�ons team has made its presence in 8th GIPC conference where Dr. Deep� Tayal presented a talk on effec�ve branding and patents. She drew the spotlight on how effec�ve patent searching can be a tool for effec�ve branding and innova�on. She suggested a coherent patent marke�ng strategy which would increase the brand value of organiza�on. She expounded upon the proficiency in securing and managing patent rights to expand overall brand reputa�on.

Ingenious e-Brain Solu�ons in 8th Global Intellectual Property Rights Conven�on (GIPC)