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SAN DIEGO (CNS) - One person was killed today in a fiery collision near Fairbanks Ranch Country Club.The crash, which involved a big rig and another vehicle, happened at about 12:30 p.m. in the 14900 block of San Dieguito Road in the North City area, according to San Diego police.The accident forced a closure of the roadway in the area to allow for investigation and cleanup, SDPD public affairs Sgt. Matt Botkin said.Further details about the collision were not immediately available. 495

SAN DIEGO (CNS) - San Diego-based medical equipment manufacturer ResMed Corp. has agreed to pay more than .5 million to resolve allegations that it paid kickbacks to suppliers, sleeps labs and other health care providers in exchange for referrals and prescriptions for its products, the Department of Justice announced Wednesday.The government accused ResMed of violating the Anti-Kickback Statute of the False Claims Act by providing free or below-cost medical equipment to companies in several states. Court documents state that ResMed's products -- which treat sleep apnea and other sleep disorders -- were provided to companies that in some cases began writing prescriptions to their patients entirely for ResMed equipment.Prosecutors say some examples of ResMed kickbacks included free home sleep testing devices, free or below-cost positive airway pressure masks and diagnostic machines, and free telephone call center and patient outreach services that allowed the companies to order resupplies for sleep apnea patients.RELATED: San Diego suing SDG&E for allegedly delaying pure water projectThe settlement agreement resolves five lawsuits filed by whistleblowers, who will collectively receive around .2 million out of the total settlement."Paying any type of illegal remuneration to induce patient referrals undermines the integrity of our nation's health care system," said Assistant Attorney General Jody Hunt. "When a patient receives a prescription for a device to treat a health care condition, the patient deserves to know that the device was selected based on quality of care considerations and not on unlawful payments from equipment manufacturers." 1679

SAN DIEGO (CNS) - San Diego-based Agena Bioscience announced today that its diagnostic system for detection of SARS-CoV-2, the virus that causes COVID-19, received Emergency Use Authorization from the U.S. Food and Drug Administration.The company was granted approval Monday on an emergency basis for its MassARRAY SARS-CoV-2 panel for use in clinical laboratories.The FDA's Emergency Use Authorization allows for the use of unapproved medical products during an emergency to diagnose, treat or prevent serious or life-threatening diseases or conditions. Emergency Use Authorization has been granted to a large number of companies since the COVID-19 pandemic began for rapid approval of diagnostic tests, personal protective equipment, ventilators and other devices.``Agena is proud to offer a truly scalable platform to support the increasing demand for high-throughput SARS-CoV-2 testing,'' said Agenda CEO Peter Dansky. ``To address the crisis presented by COVID-19, labs need to cost- effectively process large numbers of samples. The MassARRAY System is the perfect tool for that.''The company says its panel targets five regions of the viral genome, and that with its authorization, the company hopes to help laboratories increase testing without the concerns of instrument or reagent availability.``The unique characteristics of the Agena detection technology provide significant supply chain advantages,'' said Jason Halsey, Agena's senior vice president of technology and operations. ``Agena proactively sourced and secured materials to provide uninterrupted product availability to our customers. Agena's MassARRAY SARS-CoV-2 panel kits and instruments are ready for immediate deployment, and we are equipped to supply mill 1741

SAN DIEGO (CNS) - San Diego County public health officials have reported 540 new COVID-19 infections and one new death related to the illness, raising the region's total to 59,656 cases and 908 deaths as the county continues to await news on whether it will sink into the dreaded purple tier of the state's four-tiered COVID-19 reopening plan.State officials reported Wednesday that San Diego County had an unadjusted new daily coronavirus case rate of 8.7 per 100,000. The adjusted case rate had dropped to 7.4 per 100,000, above the baseline of 7, qualifying the state for the purple, or most restrictive tier of the reopening plan. Last week's unadjusted case rate was 7.8 per 100,000.According to the reopening plan, a county has to report data exceeding a more restrictive tier's guidelines for two consecutive weeks before being moved to that more restrictive tier. A county then has to be in that tier for a minimum of three weeks before it may move to a less restrictive tier.San Diego County has been in the red tier for months, skirting but ultimately avoiding the purple tier, which would necessitate the closure of almost all indoor operations of nonessential businesses. Recent trends have shown a slow but steady increase in infection numbers.If the county cannot drop its adjusted daily case rate below 7 per 100,000, indoor operations in locations such as restaurants, museums, places of worship, breweries and retail businesses will have to either close entirely, move to outdoor operations only or modify in other ways.In recent weeks, the region had an unadjusted rate well above the purple tier guidelines, but a significant effort to increase the volume of tests had allowed for an adjustment to bring it back to the red, or substantial, tier.Dr. Wilma Wooten, the county's public health officer, said retail operations, including indoor shopping centers, will be limited to 25% of building capacity, down from the current 50%. Schools, unless they have already restarted in-person learning, will be restricted to distance learning. K-12 schools already in session can continue, Wooten said."Cases are increasing in the region and it is vital that we take this virus seriously and recommit ourselves to the strategies that are proven to work," she said Thursday. "Wear a face covering when you go out in public, stay six feet away from others and avoid crowds and large gatherings."The county's testing positivity rate actually improved, declining 0.3% from last week to reach 3.2%, but remains high enough for this metric to remain in the orange tier.The state's health equity metric, which looks at the testing positivity for areas with the least healthy conditions, increased from 5.1% to 5.3% and entered the red tier. This metric does not move counties backward to more restrictive tiers, but is required to advance.The state data reflect the previous week's case data to determine where counties stand. The next update will be Tuesday. 2970

SAN DIEGO (CNS) - Sen. Kamala Harris questioned U.S. Customs and Border Protection Commissioner Kevin McAleenan on the economic fallout of last month's nearly six-hour closure of the San Ysidro Port of Entry during a Senate Judiciary Committee hearing Tuesday in Washington, D.C. CBP fully closed the San Ysidro Port of Entry to vehicles from 11:30 a.m. to around 5 p.m. Nov 25 after a group of asylum-seeking members of the migrant caravans in Tijuana attempted to cross the border and illegally enter the U.S. CBP agents used tear gas and pepper ball guns to quell the crowds. According to Harris' office, businesses in the city of San Ysidro lost .3 million due to the closure. Roughly 5 billion in annual gross regional product in San Diego and Imperial counties is reliant on interborder commerce. ``You can appreciate that there's a lot of concern in that part of our state from business owners, especially when the president has threatened to `permanently close the border,' that there would be real economic harm to that region,'' Harris said. According to McAleenan, the agency remains in daily contact with the San Diego Association of Governments and the San Diego Regional Chamber of Commerce regarding the closure and its economic effects. The CBP is also conducting a review of the incident, which McAleenan said happens after every use of force. ``I personally wrote into our operational plan the need to maximize legitimate trade and travel while we made sure that any caravan arrival would be managed in a safe way, so I delegated that authority to the lead field coordinator in San Diego area,'' McAleenan said. ``They actually opened it up a little bit before they felt that we had full resolution, because they thought it was a secure enough situation. And they worked very hard to catch up on the traffic backlogs.'' Harris also requested data from the CBP on how many migrants the agency has referred for prosecution for trafficking allegations. Federal officials, including Department of Homeland Security Secretary Kirstjen Nielsen, have suggested that a significant number of migrants pose as so-called ``fraudulent families'' in order to gain asylum. Federal officials have also argued that the Trump administration's family separation policy was an effort to deter such practices. ``We are tracking our criminal referrals carefully, and we can certainly cross-designate that with the folks that have been part of a fraudulent family unit, so we'll share that with the committee, as well,'' McAleenan said. 2545